Events

Retiro De Equipo (Recall) de ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    142920
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-05-27
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Ethicon is recalling the product following an analysis of unpublished data from two large independent hernia registries. recurrence / reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh flexible composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries. ethicon is unable at this time to characterize all factors contributing to higher rates and is therefore removing the product from the global market.

Device

ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH
  • Modelo / Serial
    Model Catalog: PHY3050R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY3035R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2535V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2030R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY0715R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1520V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1520R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1515Q (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1015V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2025V (Lot serial: >100 NUMBERS (ALL LOTS))
  • Descripción del producto
    PHYSIOMESH FLEXIBLE COMPOSITE MESH
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC