Events

Retiro De Equipo (Recall) de TESTICULAR IMPLANT SILICONE ELASTOMER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDIHUB INTERNATIONAL 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
    133615
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-12-10
  • 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
    On september 17th 2015 silimed had its ce mark suspended due to the discovery of microscopic particles on the surface of some of its implants tested by tuv in a recent audit. silimed has been given a limit period of 90 days to produce technical reports and treat the non-conformities reported.

Device

TESTICULAR IMPLANT SILICONE ELASTOMER
  • Modelo / Serial
    Model Catalog: 3232-050 (Lot serial: 8471004); Model Catalog: 3232-045 (Lot serial: 8471004); Model Catalog: 3232-040 (Lot serial: 8471004); Model Catalog: 3232-030 (Lot serial: 8471004); Model Catalog: 3232-050 (Lot serial: 8474209); Model Catalog: 3232-045 (Lot serial: 8474209); Model Catalog: 3232-040 (Lot serial: 8474209); Model Catalog: 3232-030 (Lot serial: 8474209); Model Catalog: 3232-050 (Lot serial: 8474210); Model Catalog: 3232-045 (Lot serial: 8474210); Model Catalog: 3232-040 (Lot serial: 8474210); Model Catalog: 3232-030 (Lot serial: 8474210); Model Catalog: 3232-050 (Lot serial: 8474211); Model Catalog: 3232-045 (Lot serial: 8474211); Model Catalog: 3232-040 (Lot serial: 8474211); Model Catalog: 3232-030 (Lot serial: 8474211); Model Catalog: 3232-050 (Lot serial: ALL LOTS); Model Catalog: 3232-045 (Lot serial: ALL LOTS); Model Catalog: 3232-040 (Lot serial: ALL LOTS); Model Catalog: 3232-030 (Lot serial: ALL LOTS); Model Catalog: 3521-140 (Lot serial: 4442190); Model Catalog: 3521-120 (Lot ser
  • Descripción del producto
    TESTICULAR IMPLANT SILICONE ELASTOMER
  • Manufacturer
    MEDIHUB INTERNATIONAL INC.

Manufacturer

MEDIHUB INTERNATIONAL INC.
  • Dirección del fabricante
    AJAX
  • Source
    HC