Events

Alerta De Seguridad para ETHICON SURGICAL SILK * - ANVISA REGISTRY No. 10132590027 -. Code 1187T Lot 553916 Description Silk: BIk 4-0 45cm E-15, Code 1732G Lot 554778 Description Silk: BIk 6-0 45cm (2) TG 140-8 Ps Code P639T Lot 554779 Description Silk: Blk 6-0 45cm Pl PRIME , Code 7733G Lot 554984 Description Silk: BIk 7-0 45 (2) TG 140-8 Ps, Code 7819G Lot 554985 Description Silk: Vrgn Blu 8-0 45 2xTG 140-9 Ps, Code P639T Lot 555650 Description Silk: BIk 6 -0 45cm Pl PRIME, Code 1767G Lot 557158 Description Silk: BIk 8-0 45cm (2) TG 1 00-8Ps, Code 1753G Lot 557606 Description Silk: BIk 8-0 30cm (2) TG 175-8Ps, Code P640TA Lot 557925 Description Sut. Silk PT 5-0 45cm lAgo P-3, Code P639T Lot 558841 Description Silk: Blk 6-0 45cm Pl PRIME, Code 790G Lot 558847 Description Silk: Blk 4-0 45cm CI, Code P1686T Lot 559221 Description Silk: BIk 5- 0 45cm PS-4 PRIME

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & johnson Produtos Profissionais Ltda.

¿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
    728
  • Fecha
    2003-08-18
  • 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
    Verify that you have received Product Pickup Notification letter. Identify and discontinue use of all listed lots. For further information, please contact Johnson & Johnson Professional Products Ltda. (12) 39321605, or your local representative.
  • Causa
    Probability of a small perforation in the transparent film of the external packaging compromising the sterility of the product.
  • Acción
    The company informs that it started collecting the lots involved on 14.08.2003, and informed all customers of the diversion presented by the product, where it requests the segregation until the collection thereof by a representative of Johnson & johnson Produtos Profissionais Ltda. It also informs the immediate interruption of the manufacturing process and initiation of investigation to determine the root causes of the deviation and determine corrective actions to eliminate them. On October 31 2003, the company informs that of the 19.1% of the envelopes used received no complaints related to possible problems of sterility, and that collected a total 78.6% of the envelopes marketed, remaining the same awaiting the return of the remainder.

Device

ETHICON SURGICAL SILK * - ANVISA REGISTRY No. 10132590027 -. Code 1187T Lot 553916 Description Si...

Manufacturer

Johnson & johnson Produtos Profissionais Ltda
  • Source
    ANVSANVISA