Events

Retiro De Equipo (Recall) de UNIVERSAL ELECTROSURGICAL PATIENT PLATES

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por 3M CANADA COMPANY.

¿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
    100634
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-11-09
  • 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
    This voluntary recall follows confirmation of a single user report from outside of canada which resulted in 3m identifying an unintended material (process liner) in the product. the presence of a process liner may prevent or impede the safe return of electrosurgical current following electrosurgical unit (esu) activation. this defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body due to increased impedance at the pad application site.

Device

UNIVERSAL ELECTROSURGICAL PATIENT PLATES
  • Modelo / Serial
    Model Catalog: 9135-LP (Lot serial: 2019-02DB); Model Catalog: 9135-LP (Lot serial: 2019-02CY); Model Catalog: 9130 (Lot serial: 2019-02CY); Model Catalog: 9130 (Lot serial: 2019-02DT); Model Catalog: 9130 (Lot serial: 2019-02DB); Model Catalog: 9135-LP (Lot serial: 2019-03DU); Model Catalog: 9130 (Lot serial: 2019-03DU); Model Catalog: 9135-LP (Lot serial: 2019-02DT)
  • Descripción del producto
    UNIVERSAL ELECTROSURGICAL PAD
  • Manufacturer
    3M CANADA COMPANY

Manufacturer

3M CANADA COMPANY
  • Dirección del fabricante
    LONDON
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    HC