Events

Alerta De Seguridad para ETHIBOND * POLYSSTER SUTURE - ANVISA REGISTRY No. 10132590044. Code B551T Lot 558109 Description Ethibond * Grn 4-0 75cm (2) RB-1 M, Code B552T Lot 556626 Description Ethibond * Grn 3-0 75cm 2xRB-I Mst, Code B552T Lot 559720 Description Ethibond * Grn 3-0 75cm 2xRB -I Mst, Code B553T Lot 554991 Description Ethibond * Grn 2-0 75cm 2xRB-1 Mst, Code B553T Item 559231 Description Ethibond * Grn 2-0 75cm 2xRB-1 Mst, Code B557T Lot 558110 Description Ethibond * Grn 4-090 RB -l Mst, Code BR44T Lot 556772 Description Ethibond * Grn O 75cm (2) TEl, Code BR44T Lot 558091 Description Ethibond * Grn O 75cm (2) TEl, Code BR44T Lot 558091 Description Ethibond * Grn O 75cm BR762T Lot 556625 Description Ethibond * Grn 3-075 2xSH-1 Mst, Code BR762T Lot 558075 Description Ethibond * Grn 3-0 75 2xSH-1 Mst, Code BR763T Lot 554992 Description Ethibond * Grn 2-0 75 2xSH-1 Mst, Code BR763T Item 555704 Description Ethibond * Grn 2-075 2xSH-I Mst

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
    731
  • 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 to determine corrective actions to eliminate them. On October 31, 2003, the company informs that 37.3% of the envelopes used did not receive any complaints related to possible problems of sterility, and that it collected a total of 61.1% of the envelopes marketed, remaining the same awaiting the return of the remainder.

Device

ETHIBOND * POLYSSTER SUTURE - ANVISA REGISTRY No. 10132590044. Code B551T Lot 558109 Description ...

Manufacturer

Johnson & johnson Produtos Profissionais Ltda
  • Source
    ANVSANVISA