Events

Retiro De Equipo (Recall) de PRIME CARE TRANSCEND MATTRESS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CAN-MED HEALTHCARE.

¿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
    17268
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-11-26
  • 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
    The manufacturer has issued a voluntary field correction due to the potential for the mattress to delaminate (layers of the mattress product separating from each other).

Device

PRIME CARE TRANSCEND MATTRESS
  • Modelo / Serial
    Model Catalog: SP03-TCM4284 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SP03-TCM4280P (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SP03-TCM4280 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SP03-TCM3584 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SP03-TCM3580P (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SP03-TCM3576 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SP03-TCM3580 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SP03-TACM3580 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SP03-TACM3580P (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SP03-TACM3584 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SP03-TACM3576 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SP02-PPBM426P (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SP02-PPBM427 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SP02-PPBM397 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SP02-PPMB546 (Lot serial: >10 NUMBERS CONTACT MFG); Mod
  • Descripción del producto
    Primus Transcend Mattress
  • Manufacturer
    CAN-MED HEALTHCARE

Manufacturer

CAN-MED HEALTHCARE