Events

Alerta De Seguridad para 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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    85
  • Fecha
    2001-05-04
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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
  • Causa
    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.
  • Acción
    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