Events

Alerte De Sécurité sur FLEXIMA, FLEXIBLE URETHANE CATHETERS: (1) 4 FR X 70 CM, (2) 5 FR X 70 CM, (3) 6 FR X 70 CM, (4) 7 FR X 70 CM, (5) 8 FR X 70 CM. ITEMS NO.: (1) 400-215, (2) 400-216, (3) 400-217, (4) 400-218, (5) 400-219; ALL LOT NUMBERS.

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.

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
    85
  • Date
    2001-05-04
  • 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
    07/07/2001 - BOSTON SCIENTIFIC DO BRASIL LTDA ANNOUNCES THAT BOSTON SCIENTIFIC CORPORATION LTDA STARTED A VOLUNTARY COLLECTION OF ALL LOTS OF CODES 400-215, 400-216, 400-218 AND 400-219 OF THE FLEXIBLE DRAIN CATECHISM PRODUCT , DUE TO THE FACT OF RECEIVING SOME NOTICES RELATED TO THE RADIOPACA TIP WHICH RELIEVED FROM CATHETER, AND THAT NO COMPLICATION OR SURGICAL INTERVENTION WAS REPORTED, HOWEVER, THE COMPANY DECIDED TO COLLECT THE PRODUCT FROM THE MARKET TO PREVENT FUTURE OCCURRENCE. IT FURTHER INFORMES THAT THE PRODUCT IS REGISTERED IN BRAZIL HAS NEVER BEEN IMPORTED BY BOSTON SCIENTIFIC DO BRASIL LTDA JUST FOR THE FACT THAT IT WAS REMOVED FROM THE MARKET. FOR FURTHER CLARIFICATION: (11) 56448500
  • Cause
    The radiopacle flexible tip can release the catheter. the distributor started the removal with a letter sent on november 30, 2000. the signature given no information to ecri.
  • Action
    MAKE SURE YOU HAVE RECEIVED THE BOSTON SCIENTIFIC REMOVAL LETTER ON NOVEMBER 30, 2000. IDENTIFY, ISOLE AND DO NOT USE THESE PRODUCTS. FOR FURTHER INFORMATION CONTACT YOUR BOSTON SCIENTIFIC REPRESENTATIVE OR PHONE (0021-1-508-650-8000).

Device

FLEXIMA, FLEXIBLE URETHANE CATHETERS: (1) 4 FR X 70 CM, (2) 5 FR X 70 CM, (3) 6 FR X 70 CM, (4) 7...

Manufacturer

Boston Scientific
  • Source
    ANVSANVISA