Events

Alerte De Sécurité sur CATETER THERMOCOOL SMARTTOUCH, Model - Thermocool Smarttouch Bi-directional and Thermocool Smarttouch Uni-directional, Registration nº 80145901380.

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 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER INC..

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
    1467
  • Date
    2014-11-24
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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 the research, including the medical evaluation of the health risk profile of the post-marketing reports, Biosense Webster believes that the general risk profile of these catheters is still within acceptable limits when used in the indicated population. To date, no harm or adverse events have been reported in patients as a result of this type of occurrence. The manufacturer would like to stress that there is no flaw or deterioration in the characteristics associated with these products. Therefore, the product may continue to be used.
  • Cause
    The registrant reports that biosense webster, a division of johnson & johnson medical nv / sa, has observed 34 complaints with a frequency of 0.03% related to bending / breaking in different locations on the stem (body) of the thermocool smarttouch catheter, during the period from january 2012 to july 2014. none of these reported claims were associated with adverse events. through the investigation, manual pre-casting of the distal catheter shaft and the use of 8 fr sheaths have been identified as the two primary causes for these events, and may be related to the process of using the products. additional note: this is a voluntary communication from the manufacturer to the customers regarding the event reported through customer complaints. the information contained in this field safety notification is not related to defect or any other defect of the products mentioned.
  • Action
    The company requests that the information contained in the Customer Letter (Security Notification) be carefully read; • Pass this notice to anyone involved in your organization who needs to be informed, including the clinical staff who use the THERMOCOOL SMARTTOUCH catheters and who sign the receipt form; • Review, complete, sign and return the receipt form according to the instructions listed on the form; • Keep a copy of this letter with the product. For more information, please check the Customer Letter - Annex I

Device

CATETER THERMOCOOL SMARTTOUCH, Model - Thermocool Smarttouch Bi-directional and Thermocool Smartt...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER INC.