Alerte De Sécurité sur Trade name: Uphold Vaginal Support. Technical Name: Screens. ANVISA registration number: 10341350701. Class of risk: III. Model Affected: M0068317080. . Capio Suture Capture Device. Technical Name: Suture Gripper. ANVISA registration number: 10341350717. Class of risk: II. Model Affected: M0068311251. . Capio ™ SLIM - Suture Capture Device. Technical Name: Suture Gripper. ANVISA registration number: 10341350777. Risk class: II. Model Affected: M0068318250. . Uphold Lite with Capio SLIM - Vaginal Support System. Technical Name: Screen. ANVISA registration number: 10341350779. Risk class: III. Affected Model: M0068318170

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Boston Scientific do Brasil Ltda; Medventure Technology Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    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
    Based on our research and testing, the Instructions for Use of the following products will be updated to reflect the following technique: 1. When loading a set dart into the device, verify that the dart is properly positioned in the capture device. The tip of the dart should not protrude from the tip of the Capio Device. 2. Use light stiffness on the suture while positioning the Capio tip so as to maintain the position of the dart in the capturing device. Avoid excessive counter-traction in the suture, as this has the potential of damaging the suture during the implant. Note: The technique of maintaining light backtracking on the suture is best described as exerting tension on the suture just sufficient to keep the dart nodispositive capturing. Excessive counter-traction is best described as preventing free movement of the suture during the implant. Also, please read the letter carefully and immediately post this information in a visible place near the product to ensure that this information is easily accessible to all users of the device. Please forward this notification to any healthcare professional in your organization who needs to be aware of and to any organization to which potentially affected devices have been transferred (if appropriate). If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 12/13/2018 - Date of notification notice to Anvisa: 02/16/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    The company observed a trend towards a gradual increase in reports of suture breakage and / or rupture of both the capio ™ suture capture device and the pelvic floor kit mesh set (uphold ™ - vaginal support system and uphold lite - vaginal support system). the mesh assembly refers to the portion of the pelvic floor delivery system that is removed from the patient after the mesh implant. as a result, bsc is voluntarily initiating a field safety notification for the technique of using these devices. in this way, letters with clarifications of the technique will be sent to the affected customers. there is no risk to patients who have already received the implant from the device.
  • Action
    Field Action Code 92201802-FA triggered under the responsibility of the company. Boston Scientific do Brasil Ltda. The company will inform customers