Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
Additional information in the Alert Messages released by Siemens, available at: http://portal.anvisa.gov.br/wps/wcm/connect/92c13f004d2ced31ae03fe4031a95fac/Messagem_de_Alerta_Syngo_Plaza.pdf?MOD=AJPERES and http://portal.anvisa.gov .br / wps / wcm / connect / 1d3081004d2cece7addcff4031a95fac / Message_of_Alerta_Syngo_Imaging.pdf? MOD = AJPERES
Cause
Incorrect pixel density value for images with a pixel depth greater than 12 bits. the problem affects the "region of interest", "pixel lens", "edge enhancement" and "histograms" functions.
Action
The company is developing a new software version (Syngo Imaging XS VA70B_0113) to solve the problem, which should be available until March 2013. Until the problem is corrected you should not use the functions mentioned above for images with a depth of pixels larger than 12 bits. Let the operators know about the problem and fix a warning near the location of data acquisition / manipulation (images), informing about the restrictions of use of the system.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
SAFETY ALERT
Cause
Recent events linked by the media point out that due to the administration of solutions by erroneous routes, unfavorable outcomes have occurred, with a serious consequence for the patients. examples disclosed in brazil were deaths in health services associated with intravenous feeding. however, it is known that this is not a problem only in brazil, but it is world wide. several factors contribute to this and all must be considered, since the objective is to evaluate how the chain of triggering of such errors occurs and to propose systemic interventions in order to prevent such errors and to provide safety to the patient and the user of the product . this vision refers to the importance of knowing in what context these errors occur, hence the stimulus to their notification. in practice, what is observed is that such situations are not notified, but are publicized in the media in such a way that it is limited to finding "the culprit", usually the professional who administered the product or who advised the family member to administer (in this case of probe power). in these cases, the actions seem to be punitive, strengthened by the appeal of public opinion. merely punitive stances inhibit reporting within the health service itself and the competent health authorities and make it difficult to analyze the problem and identify "root cause" and, consequently, to propose effective measures to address the problem.
Action
From the knowledge of some situations that can trigger this problem, initiatives already exist to minimize the risk of its occurrence. Among these initiatives, one is specifically concerned with the production of health products, the elaboration and revision of Technical Norms regarding connectors. The first published Technical Standard was ISO 594-1: 1986 - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements. Currently, the ISO 80369 (7 parts) series of standards is currently being reviewed and internalized in Brazil, which will replace ISO 594-1. Besides this series, there are others that refer to the connection with other devices, such as anesthesia devices, for example. This is a timely initiative, but the problem must be faced by noting also the other factors that involve risk with connectors. Hence the Recommendations to Avoid Misconnections, presented by the Secretary¹ of CE 26.150.01 of ABNT - Quality Management and related general aspects of health products: (i) To identify and emphasize, through training, the risks related to connection errors and to guide ways of avoiding them (2, 8, 9, 11, 12); (1), (2), (2), (3), (4), (5), (6), (7), (8) 12); (iii) .Do not modify or adapt the connector in its use. This may compromise their safe use (1, 4, 6, 7, 10); (iv). Tubes and catheters that have different purpose for use or are applied to different systems should be secured in opposite positions (eg central venous catheter positioned towards the patient's head and nasoenteral catheter positioned towards the patient's feet) (2, 4, 7, 11) This guidance is especially important in the case of neonatal units. (v). High-risk catheters (eg epidural, intrathecal, arterial) should be labeled and should not have secondary injections (2, 11, 12); (vi). Do not force any connection. If a connection is difficult to make - it requires a lot of effort - one should consider the possibility of a connection error. Likewise, if a connection seems unsecured, check if the components are correct (3, 9, 10); (vii). Only make connections under suitable lighting conditions. (5, 6, 7); (viii) .Reconnect the connections and track all tubes and catheters of a new patient in the industry (2, 5, 6, 7, 11, 12); (ix). Inform non-clinical collaborators, patients and their families to request assistance from the nursing or medical staff, whenever there is a need to connect or disconnect devices or infusions (1, 2, 5, 6, 7, 8, 11); (x). Identify and manage environmental conditions and practices that may contribute to the fatigue of the health professional and take appropriate actions to avoid them. (2, 5, 6, 7, 11); (xi). To notify adverse events arising from connection errors to the competent authority (3, 5). In addition to these Recommendations, we suggest reading materials available at the following addresses: (i) .http: //www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm127745.htm (ii) .http: // www. ismp.org/newsletters/acutecare/articles/catheter-Misconnections.asp (iii) .https: //www.premierinc.com/safety/topics/tubing-misconnections/resources.jsp ¹ Recommendations for Avoiding Misconnections - Systematized by Elaine Koda, nurse, risk management specialist (ISO 14971 and ISO 31000). Secretary of CE 26.150.01 - "Quality management and related general aspects of health products", WG 6 Rapporteur and member of ISO / TC 210 JWG4.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
If the Centrifuge System malfunctions during cardiopulmonary bypass, the risk to the patient ranges from insignificant to severe, and depends on: • the patient's condition; • how quickly the user responds to malfunction. If used as the arterial pump, a defect can result in: • Loss of arterial flow. The patient's resulting damage can range from a temporary and well-tolerated reduction in blood pressure to cell death, resulting in neurological dysfunction, cardiac dysfunction due to inadequate myocardial circulation, end-organ dysfunction, or death in the event of a long period of no flow; • Reflux condition. This could result in: exsanguination of the patient leading to hypovolemia; entrainment of the air at the site of the aortotomy leading to a surgical intervention to remove the air to prevent neurological or end organ damage or dysfunction. If the system is used for assisted venous drainage (an infrequent application), a defect may result in: • inadequate venous drainage. This can lead to hypoperfusion if venous drainage is insufficient to maintain adequate blood flow. Any malfunction can result in user distraction and a potential delay of the process.
Cause
Malfunction of the battery backup system for sarns ™ centrifuge system.
Action
Observe carefully the instructions contained in the Appendix - Letter to Customers.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
Ethicon Endo-Surgery has initiated a voluntary recall of all PSX Proximate® Skin Staple Extractors products because of the possibility that damage to the packaging may have compromised the sterility of the product. The problem was detected internally during the packaging process. No customer complaints related to this issue were received, as well as no adverse event reports associated with the product under recall. Ethicon Endo-Surgery has stopped production and shipment of the affected product and is investigating the root cause of the packaging problem and will implement actions to resume production. There are no notifications to date in the NOTIVISA system. Anvisa follows this action.
Cause
Possibility of compromising the sterile barrier of the package.
Action
Users are advised to: See annex. http://portal.anvisa.gov.br/wps/wcm/connect/35191e004d6326a7b574f5c116238c3b/Carta_aos_Hospitais.pdf?MOD=AJPERES 1. Inspect your inventory immediately to see if you have the affected product, and separate those products. View detailed images to help identify affected products. 2. Fill out the Business Response Form and fax it to (11) 3030-1109 or return it to your local sales representative within 3 business days of receiving this notice, even if you do not have the product affected. Mention Event 5928. If you have any product to be returned, keep a copy of this form in your records. 3. To return the affected product, take a xerox copy of the completed Business Response Form, place it in the box along with your product, and attach the pre-printed shipping label and mail it to the company's local warehouse. 4. Share this information with all appropriate personnel in your facility. 5. As for any medical device, adverse reactions or quality problems, occurring in the use of this product, may be reported to the local representative.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
Check for additional information in the Kimberly-Clark Customer Letter document. The document is available at http://portal.anvisa.gov.br/wps/wcm/connect/496126804d6f9bcdbea8ffc116238c3b/Carta_ao_Cliente_1198.pdf?MOD=AJPERES. The Technovigilance Unit is following up on this case.
Cause
Primary packaging of the product may be open, which compromises its sterility.
Action
The product in question is being collected by the registration holder. If you have any affected product, segregate it (identify it appropriately to avoid inadvertent use), and contact the company to report the fact through the Product Field Action Response Form. The form and the contact phone number of the company are available in the Letter to Customers document.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
Philips recommends the following measures: • Operate the XL with AC power instead of battery power only. • If you need to operate the XL with battery power only, make sure the battery is of a different Manufacturing Date (it should not have code R-2011-12 for the Date of Manufacture). • If you can not operate with AC power only or find a battery with a date of manufacture other than the one identified above, use an alternative energy source for treatment or therapy (eg, defibrillator / standby monitor). Access security letter to customers and lots involved in: http: //portal.anvisa.gov.br/wps/wcm/connect/a71f70004d731b5a890ae9c116238c3b/Aviso_de_Seguranca_FCO86100117A.pdf? MOD = AJPERES
Cause
If the xl defibrillator / monitor (m4735a) is used in a patient when ac power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a warning message or low battery tone. there is potential for harm to the patient if the xl shuts off or becomes inoperable when in clinical use to provide therapy (ie defibrillation or non-invasive cardiac pacing) note: the xl is capable of running on ac power without a battery.
Action
corrective action: Safety Notice (FSN) informing affected customers about the possible problem and action to be taken, as well as arranging for the replacement of affected customers' batteries at no charge as soon as new production is available. A Philips Healthcare representative will contact customers with the affected batteries to arrange replacement. Any information or support regarding this issue, please contact us on 0800 701 77 89, Monday to Saturday service from 7am to 7pm.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
• Problem Description Number 1: Use a language other than Chinese • Issue Description Number 2: Do not change to the Agatston protocol before clicking "ok" in the "Side Dialog Box." Problem Description Number 3: Do not add the control point for a spline line • Edit the existing lines, or use a different type of line in Common Tools - Spline Measurement • Problem Description Number 4: In the CT (CTV), first copy the data to the Local and then load to and measure the SUV values Or, load the data into the CT and measure the SUV values in the Slab stage • Problem Description Number 5: On (CTV), copy the data into the Location and then press and measure HOW TO IDENTIFY THE AFFECTED PRODUCTS: The following instructions can be performed to identify the software version of the product: • Click on the button Help "[Help], • Select" About "[About], and the software version is displayed. If you have software versions: 4.0.2, V4.5.2 or V4.5.3, affected Additional information or support for this problem please contact your local Philips representative or your local Philips Healthcare office. If you need any information or support regarding this issue, please contact us by phone: 0800 701 77 89 Monday to Saturday service from 7am to 7pm. Access security letter to clients and lots involved in: http: //portal.anvisa.gov.br/wps/wcm/connect/cf628b004d79453f8f7cefc116238c3b/Aviso+de+Seguran+FCO72800548.pdf? MOD = AJPERES
Cause
1. when translating the results from (cs) to chinese, the percentile is not accurately reported. 2. in the (cs) protocol, the protocol is changed to, however, the name of the protocol remains agatston. 3. spline metering values are not updated by adding control point (cp) and changing row length. 4. in ct (ctv) pet studies being loaded from a remote source other than 1, appears incorrectly in the 2d scene and are not presented with the correct suv values. 5. when loading pet images into the ct (ctv) \ from remote source other than 1, different images appear incorrectly with wrong suv values and qr.
Action
Philips Healthcare is notifying all affected consumers and will install updated software via Request to address these issues. The Philips service department will contact everyone to schedule a time to conduct the appropriate fix and implement the updated software.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
According to the company Brainlab Ltda, treatment plans for the M3 MICRO MULTILINE COLLECTOR typically contain pairs of closed blades and ideally no dose should be administered through the small space remaining between the tips of the enclosed blades of the equipment. However, according to the company a small leak is technically unavoidable, unless this blade gap is covered by the linear accelerator collimator (primary collimators). Therefore, to avoid administering a dose to the patient with undesired radiation leakage, it is essential that the space between the pairs of closed blades of the M3 is always completely protected by the primary collimators of the linear accelerator. If the leaked dose exceeds the clinically desirable limits for a particular treatment plan, severe injury to the patient may result. According to the company, no adverse events related to the problem in question have been reported so far. Anvisa's Technovigilance Unit is monitoring this case.
Cause
Possibility of a small leakage of radiation through the gap between the slides of the equipment, during the application of the therapy.
Action
Brainlab said it had already communicated the clients involved about the problem by letter. The corrective action of the company consists of an update of the instructions of use of the equipment, alerting to the use of the equipment in its correct configuration. If you have the equipment in your inventory, make sure that the linear accelerator primary collimators always fully cover the clearance of the closed blades of the Multi-Collimator M3 Multi Collimator. Read also the alert message published by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/7616c6004d79898d903ef1c116238c3b/16+de+novembro+Messagem+de+alerta.pdf?MOD=AJPERES .
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
A certain component of the equipment - responsible for securing a pin to its original position - has not been adjusted correctly, which can cause the pin to come loose and leave some parts of the system loose, with the possibility of detaching. According to Siemens, the possibility of adverse events related to the operation of the system or the detachment and falling of parts, especially in the event of a collision with the equipment, can not be ruled out. The verification of the equipment has not yet been programmed by the company.
Cause
No locking pin on the equipment, which can come out of position and let loose some parts of the system.
Action
Siemens has already informed its customers of the problem and that a timeline for correction will be scheduled - the start date of the correction was not reported by the company.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notes supplémentaires dans les données
Action
Safety note (FSN 2018-02) from 3M Deutschland GmbH on the surgical professional scissors Surgical Clipper Professional model 9681
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
Anvisa takes this measure considering that, in Investigative Inspection on 09/12, the company was not located at the declared address. In addition, the Sanitary Vigilance of Joinvile reported that the company had requested the shutdown of its manufacturing activities in 05/2012. Invoices were evidenced after this date. In Investigative Inspection was spotted production in place without Operation Permit. Anvisa / Utvig follows this case.
Cause
Suspension determination of manufacturing, distribution, trade and use. seizure and destruction of existing stock in the market, according to resolution - re n °. 4,843, dated november 12, 2012. dou n ° 219 of 11/13/2012 attached. http://portal.Anvisa.Gov.Br/wps/wcm/connect/41c92d804d87ef40a4e5e5c116238c3b/re4.843.Pdf?mod=ajperes.
Action
Check the product for stock and segregate. Do not use the product. Contact your local Sanitary Surveillance to monitor product destruction. Contact supplier to negotiate refund.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
According to Medtronic Ltd., based on data from the Medtronic Implantable Systems Performance Registry (ISPR), the overall failure rate of the SynchroMed II pump, at 78 months after implantation, is 2.4% when it is used to infuse approved drugs, and 7.0% when used to infuse non-approved drugs. The use of unapproved drugs can lead to intermittent or permanent pump motor blockages, which can be reported as a loss of or change in therapy - pumps may present motor blockages when used with approved or unapproved drugs, however, of the pump motor were reported at a significantly lower rate when only approved drugs are used (as quoted above). Additional information: Alert message published by the company at: http://portal.anvisa.gov.br/wps/wcm/connect/1a4a23004d9b08eab88ef9c116238c3b/Carta_de_Comunicacao_ao_Cliente.pdf?MOD=AJPERES. List of drugs approved for use in Synchromed pumps: http://portal.anvisa.gov.br/wps/wcm/connect/4c479d804d9b095bb897f9c116238c3b/Lista_dos_Farmacos_Aprovados.pdf?MOD=AJPERES Report on increased risk of engine crash: http: / / / / / / / #### UPDATE (03/13/2013): This field action was finalized by Medtronic Comercial Ltda on 02/02/2013 (see file 0126047 / 13-2). The company showed the sending of warning messages to customers who own the product at risk. ####
Cause
Use of non-approved drugs for synchromed infusion pumps may increase the chance of intermittent or permanent motor blockage, leading to underdosing or loss of therapy.
Action
The company is sending an alert message ("Urgent Safety Warning - Use of Unapproved Drugs with the Synchromed Implantable Infusion Pump), with information about the problem and ways to avoid it - not using drugs that have not been approved for the product concerned.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
The company informs that this field action is in a global scope and that there was no receipt of any claim in Brazil. Further informs that this recall does not apply to cannulae with 8 digit lot numbers packed with the Amvisc Plus product; also does not apply to the viscoelastic contained in the glass syringes of the Amvisc Plus product. To date, no notifications have been identified in the NOTIVISA. UPDATE: The company updated the information on 1/30/2013 and added two more batches affected by the field action: D100016A and D090105D. For more information, please contact Customer Service at 08007026464, or e-mail: maria.iung@bausch.com
Cause
Bausch + lomb, inc. recently identified that some disposable canisters (with a 4-digit batch number) supplied with the dvo amvisc plus are not fitting properly to the luer-lock in the sterile glass syringes of amvisc plus. disposable cannulae with 4-digit lot numbers may leak viscoelastic material or dislodge the syringe during injection. the immediate consequence of cannula detachment during intraocular use could involve damage to the intraocular tissue, which may or may not have far-reaching consequences, depending on the specific tissue involved and the nature of the injury.
Action
Discontinue use of the affected lots of Amvisc Plus DVO immediately.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
According to the manifestation of the company, in compliance with RDC 23/2012, the available units were identified and collected. If any customer still identifies any units in their inventory, please contact the company for arrangements regarding product pick-up.
Cause
A foreign body was found in the sealed packaging of the polymed safety scalp product.
Action
The Sanitary Vigilance of the Municipality of São Paulo determined the prohibition and collection of the product, through publication in the Official Gazette of the City of São Paulo (DOC) of 04/20/2012 page 105, COVISA Communiqué Nº. 006/2012
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
According to the manifestation of the company the use of the product with quality deviation can lead to the result of altered biological culture. In compliance with RDC 23/2012, the company also informs that the available units were identified, collected and destroyed on 09/09/2012. If a customer still identifies a unit in their inventory, please contact the company to arrange for the product to be collected by e-mail sac@laborimport.com.br or telephone (11) 4197-5980. //// UPDATE 10/01/2014 - The company submitted a form finalizing the field action, considering that there was no further contact of customers for the return of the product since February 2013.
Cause
The product presented an unsatisfactory result regarding the appearance and sterility tests, according to the report of analysis nº 981.Cp / 2012, for lot 20110312, manufacture 12/03/2011, validity 03/12/2016 and report of analysis 980.00 / 2012, for lot 20110814 manufacture 14/05/2011, validity 08/14/2016, issued by the instituto adolfo lutz.
Action
The Sanitary Surveillance of the Municipality of São Paulo determined the definitive ban on affected lots, through the publication in the Official Gazette of the City of São Paulo (DOC), Comunicados COVISA no. 029/2012 and Notice COVISA Nº. 34/2012, of 07/28/2012 and 08/08/2012, respectively.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
See the full text of Resolution - RE Nº 4851, of 12/11/2012, published in the Official Gazette of the Union No. 219 - Section 1, of 13/11/2012 at http://www.in.gov.br/visualiza/index. .jsp? data = 13/11/2012 & journal; = 1 & page; = 127 & total Files = 232.
Cause
All imported products requested by angioline ltda. (cnpj 02.305.681 / 0001-21), had their registrations independed at anvisa, because the company did not have the import activity in its business operation authorization (afe). in this way, anvisa determined as a measure of health interest: (i). the suspension, throughout the national territory, of the importation, dissemination, distribution, sale and use of all lots of all products imported by angioline ltda. - cnpj: 02.305.681 / 0001-21, as they are not registered with anvisa; and (ii). the collection of all units of the products mentioned in item (i) on the market.
Action
The company must collect all lots of all products.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
Stryker has received complaints regarding scales and / or bedding systems for the Go Bed Bed - mod. FL28EX, with scale or bed output (Chaperone). This unit was manufactured between March 1, 2002 and June 30, 2008. Their investigation identified that the reported problems could be attributed to the malfunctioning of charge cells. See more information in the attached Letter of Attachment. #### Update (02/01/2013): field action closed on 12/27/2012 by the record holder.
Cause
Malfunction of load cells.
Action
See attached letter. http://en.wikipedia.org/w/eng/index.php
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
The product is an injectable implant, the base of polymethylmethacrylate (PMMA), used in repairing plastics and manufactured by the company MTC Medical Trade Industry Import and Export of Biomedical Products. Anvisa found that the company was not manufacturing the product as recorded. In investigative inspection, the Agency detected the nonobservance of items foreseen in RDC 59/2000, which entails a high degree of risk to the users' health. The company must collect all available lots on the market.
Cause
Company does not manufacture the product according to the registration granted by anvisa. http://portal.Anvisa.Gov.Br/wps/wcm/connect/23caf2804db60436ad4fbdd6059e5711/re5139mtc.Pdf?mod=ajperes.
Action
Immediate disruption of use, stock segregation, product recall on the market.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
See attached Letter to the Client. Anvisa follows this Field Action. http://portal.anvisa.gov.br/wps/wcm/connect/9883f9804db6d3d6af54bfd6059e5711/Carta_ao_Cliente_1212.pdf?MOD=AJPERES #### UPDATE: 06/03/2013 - The company announces the CLOSURE of the field action. # ###
Cause
Possible lithium heparin contention.
Action
Immediately discontinue use of the affected product. Locate the affected product in stock and segregate for later recall by the record holder.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
The irregularities were detected by Anvisa on inspection carried out at the company. For additional information, access copy of RE No. 4,063 of 09/27/2012. The company has already started the process of collecting the products.
Cause
Commercialization of products not registered in anvisa (products 1 and 2) and modification of specification without authorization of anvisa (product 3).
Action
Suspension of manufacture, disclosure, distribution, trade and implantation of the aforementioned products and collection, of all units of the aforementioned products available on the market, by Incomepe Indústria de Materiais Cirúrgicos Ltda.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
According to the manifestation of the company, in compliance with RDC 23/2012, the available units are being identified for collection. If a customer still identifies a unit in their inventory, please contact the company to arrange for the product to be collected. #### UPDATE ON 09/30/2013 - The company completed the field action.
Cause
According to fiscal report 397.00 / 2010-ial / sp and proof of analysis of single sample tax, the product disposable hypodermic needle 30x07mm, val. 07/2013, lot 080708 was considered unsatisfactory in the aspect test.
Action
The Sanitary Vigilance of the State of São Paulo determined the prohibition of commercialization and use, as well as the collection of the product, through publication in the Official Gazette of the State of São Paulo (DOE) of 7/7/2012 page 31, CVS Communiqué - 52 of 4/7/2012.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
The company must proceed with the collection of units sold.
Cause
Manufacture of the product in a place without sanitary permit and without authorization of operation in this agency.
Action
ANVISA determined the suspension of the manufacture, distribution, distribution, trade and use of the product throughout the national territory, as well as the collection of all units.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
According to the company's assessment, an error has occurred and it is not a question of forgery of the product. It emphasizes that there is no risk associated with the product and / or its validity. That is, there is no risk to the health of customers / patients associated with the use of the affected product. Such an event will not cause misfortune to the clients / patients since they have received product with the expiration date informed prior to the actual expiration date of the product. ANVISA and VISA RS are following the Field Action.
Cause
Detected divergence in the date of manufacture format and validity of the shadowteck lumbar spacer in relation to the format defined in the product registration process; the divergence detected is the dates printed on the labels of products in year / month / day format, and in the product registration was defined by the format day / month / year. it was found that the label dates of the shadowteck lumbar intervertebral spacer (carton) and secondary (aluminized) carton labels were in disagreement with the dates of manufacture and validity stated on the blister, which were within the expiration date less than the defined term of two years from the date of manufacture.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
According to the company's assessment, there is no risk to the health of customers / patients associated with the use of the affected product. ANVISA and VISA RS are following the Field Action.
Cause
Discrepancy was detected in the date of manufacture and the validity of the masterteck peek lt1 screw in relation to the format defined in the product registration process. the divergence detected is the dates printed on the labels of the products in year / month / day format, and in the product registration was defined by the format day / month / year. according to the evaluation of the company has occurred error, it is not about falsification of the product and there is no risk associated with the product and / or its validity.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
Evidences originated from UTVIG investigation, with consequent sanitary inspection of Visa Campinas / SP.
Cause
Non-compliance with rdc 59/2000 with consequent publication of re 5,407 of 12/18/2012. see attached. http://eng.Wiktionary.Org/w/index.Php/.
Action
Suspension of manufacture, disclosure, distribution, trade and use. Determination of collection by the company.