Events

Alerta De Seguridad para PROLENE * POLYPROPYLENE SATURE - ANVISA REGISTRY # 10132590033 - Code 8723T Lot 554117 Description Prolene * Blue 2-0 75crn (2) SH Mst, Code 9523T Lot 554119 Description Prolene * Blue 2-0 75 2xSH-Imst, Code 9556T Lot 554762 Description Prolene * Blue 5-0 75 2xRB-Imst, Code 9556T Lot 554975 Description Prolene * Blue 5-0 75 2xRB-Imst, Code P8697T Item 554979 Description Prolene * Blue 6-0 45crn PI Prm, Code 9551T Lot 554981 Description Prolene * Blue 4l 75 2xRB-Imst, Code 8204T Lot 555060 Description Prolene * Blue 4-0 60crn (2) TF Mst, Code 8521T Lot 555262 Description Prolene * Blue 4-0 90crn (2) SH Mst, Code P8682T Lot 555263 Description Prolene * Blue 4-0 45crn PS-2 Prm, Code 8521T Lot 555733 Description Prolene * Blue 4-0 90crn (2) SH Mst, Code 9522T Lot 555734 Description Prolene * Blue 3-0 75 2xSH-Imst, Code 9556T Lot 556066 Description Prolene * Blue 5-0 75 2xRB-Imst, Code P8682T Lot 556642 Description Prolene * Blue 4-0 45crn PS-2 Prm , Code 9521T Item 556774 Description Prolene * Blue 4-0 75 2xSH-Imst, Code 9521T Item 556775 Description Prolene * Blue 4-0 75 2xSH-Imst, Code 9551T Item 557127 Description Prolene * Blue 4-0 75 2xRB-Imst, Code 8204T Lot 557159 Description Prolene * Blue 4-0 60crn (2) TF Mst, Code 8822T Lot 557349 Description Prolene * Blue 3-0 90 2xMH-Imst, Code 9556T Lot 557424 Prolene * Blue 5-075 2xRB-Imst, Code 9556T Item 557425 Description Prolene * Blue 5-0 75 2xRB-Imst, Code 8822T Item 557555 Description Prolene * Blue 3-0 90 2xMH-Imst, Code 9523T Lot 557557 Description Prolene * Blue 2-075 2xSH-Imst, Code 9556T Lot 558127 Description Prolene * Blue 5-0 75 2xRB-Imst, Code 9556T Lot 558128 Description Prolene * Blue 5-0 75 2xRB-Imst, Code P8691T Lot 558219 Description Prolene * Blue 6-0 45crn PI Prm, Code 9522T Lot 558311 Description Prolene * Blue 3-0 75 2xSH-Imst, Code 9558T Lot 558666 Description Prolene * Blue 3-0 75 2xRB-Imst, Code P8682T Lot 5586 68 Description Prolene * Blue 4-0 45crn PS-2 Prm, Code 8722T Lot 558670 Description Prolene * Blue 3-0 75crn (2) SH Mst, Code 9521T Lot 558838 Description Prolene * Blue 4-0 75 2xSH-Imst, Code 9551T Lot 559213 Description Prolene * Blue 4-0 75 2xRB-Imst, Code 8204T Lot 559214 Description Prolene * Blue 4-0 60cm (2) TF Mst, Code 8722T Lot 559230 Description Prolene * Blue 3-0 75crn (2) SH 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
    730
  • 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 of the 29.9% used envelopes did not receive any complaints related to possible problems of sterility, and that collected a total 66.2% of the envelopes commercialized, remaining the same awaiting the return of the remainder.

Device

PROLENE * POLYPROPYLENE SATURE - ANVISA REGISTRY # 10132590033 - Code 8723T Lot 554117 Descriptio...

Manufacturer

Johnson & johnson Produtos Profissionais Ltda
  • Source
    ANVSANVISA