Events

Alerta De Seguridad para MONONYLON * ETHILON * - ANVISA REGISTRY Nº 10132590062 -. Code P1663T Lot 554111 Description Ethilon * Blk 3-0 45 PS-1 PRIME, Code 7718G Lot 554544 Description Ethilon * Blk 10-0 30 2xTG 140-8Ps, Code 7718G Lot 554545 Description Ethilon * Blk 10-0 30 2xTG 140-8Ps , Code P1663T Item 554557 Description Ethilon * Blk 3-0 45 PS-1 PRIME, Code P1664T Item 554558 Description Ethilon * Blk 4-045 PS-1 PRIME, Code P698T Lot 554777 Description Ethilon * Blk 5-0 45cm P-3 Prm , Code 7718G Lot 554790 Description Ethilon * Blk 10-030 2xTG 140-8Ps, Code P1666T Item 555046 Description Ethilon * Blk 5-0 45 PS-2 PRIME, Code 7718G Lot 555513 Description Ethilon * Blk 10-0 30 2xTG 140-8Ps , Code 7718G Lot 555514 Description Ethilon * Blk 10-0 30 2xTG 140-8Ps, Code P689T Lot 555648 Description Ethilon * 6-0 45cm Pl Prm, Code P697T Lot 555649 Description Ethilon * Blk 6-0 45cm Pl Prm, Code 1165T Item 555656 Description Ethilon * Blk 6-0 45cm E-16, Code 1160T Lot 555658 Description Ethilon * Blk 6-0 45cmE-15, Code P1664T Lot 558099 Description Ethilon * Blk 4-045 PS-1 PRIME, Code KF410G Lot 556054 Description Ethilon * Blk / Slk Blk 10-0 / 4-0 30/45, Code KF310G Lot 556055 Description Ethilon * Blk / Slk Blk 10-0 / 4-0 15/45, Code P1666T Item 556627 Description Ethilon * Blk 5-0 45 PS-2 PRIME, Code P1667T Lot 557090 Description Ethilon * Blk 4-0 45 PS-2 PRIME, Code 7717G Lot 557099 Description Ethilon * Blk 9 -0 30 2x TG 140-8Ps, Code 1161T Lot 557145 Description Ethilon * Blk 5-0 45cm E-15, Code P1602T Lot 557560 Description Ethilon * Und 5-0 45 PS-4 PRIME, Code P1661T Lot 557561 Description Ethilon * Blk 5-0 45 PS-4 PRIME, Code P1698T Item 557562 Description Ethilon * Blk 6-0 45 P-3 PRIME, Code P1660T Lot 557563 Description Ethilon * Blk 6-0 45 PS-4 PRIME, Code 7719G Lot 557607 Description Ethilon * Blk 10-030 2xTG 175-8Ps, Code 1163T Lot 557610 Description Ethilon * Blk 3-0 45cm E-24, Code 1167T Lot 557611 Description Ethilon * Blk 4-0 45cm E-19, Code 7718G Lot 557717 Description Ethilon * Blk 10-0 30 2xTG 140-8Ps, Code P698T Item 557923 Description Ethilon * Blk 5-0 45cm P-3 Prm, Code P1661T Item 557926 Description Ethilon * Blk 5-0 45 PS-4 PRIME, Code P1666T Lot 558076 Description Ethilon * Blk 5-0 45 PS-2 PRIME, Code P1662T Lot 558077 Description Ethilon * Blk 4-0 45 PS-4 PRIME, Code P1603T Lot 558078 Description Ethion * Und4-045PS-4PRIME, Code 7718G Lot 558094 Description Ethilon * Blk 10-030 2xTG 140-8Ps, Code P1698T Lot 558105 Description Ethilon * Blk 6-0 45 P-3 PRIME, Code P1660T Lot 558106 Description Ethilon * Blk 6-0 45 PS-4 PRIME, Code P1668T Lot 558107 Description Ethilon * Blk 5-0 45 PS-3 PRIME, Code P1665T Lot 558108 Description Ethilon * Blk 6-0 45 PS-3 PRIME, Code P697T Lot 558256 Description Ethilon * Blk 6-0 45cm Pl Prm, Code 1166T Lot 558309 Description Ethilon * Blk 5-0 45cm E-19, Code 1111T Lot 558310 Description Ethilon * Und 4-0 45cm E-19, Code 1164T Item 558794 Description Ethilon * Blk 4-0 45cm E-24, Code 1160T Lot 559155 Description Ethilon * Blk 6-0 45cm E-15, Code 1161T Lot 559158 Description Ethilon * Blk 5-0 45cmE-15, Code P1662T Lot 559166 Description Ethilon * Blk 4-045 PS-4 PRIME , Code P1667T Item 559169 Description Ethilon * Blk 4-0 45 PS-2 PRIME, Code P1611T Item 559235 Description Ethilon * Und 4-0 45 PS-2 PRIME, Code P1663T Item 559686 Description Ethilon * Blk 3-0 45 PS-1 PRIME, Code P1664T Lot 559687 Description Ethilon * Blk 4-0 45 PS-1 PRIME, Code 1166T Lot 559724 Description Ethilon * Blk 5-0 45cm E-19, Code 1111T Lot 559914 Description Ethilon * Und 4-0 45cm E-19 .

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
    729
  • 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 31st October 2003, the company informs that 41.5% of the envelopes used did not receive any complaints related to possible problems of sterility, and that it collected a total 51.1% of the envelopes marketed, remaining the same awaiting the return of the remainder.

Device

MONONYLON * ETHILON * - ANVISA REGISTRY Nº 10132590062 -. Code P1663T Lot 554111 Description Ethi...

Manufacturer

Johnson & johnson Produtos Profissionais Ltda
  • Source
    ANVSANVISA