Events

Retiro De Equipo (Recall) de MEROCEL SURGICAL PATTIES

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

¿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
    30395
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-09-14
  • 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
    As part of a notification to all manufacturers of neurosurgical patties medtronic xomed was informed by the food and drug administration's (fda) center for devices and radiological health (cdrh) of a potential postmarket safety concern associated with the use of neurosurgical patty devices. the potential safety concern identified by the fda "is related to clinical consequences when some patties which are designed to be x-ray detectable or radiopaque to assist with post-procedural removal in the event of a missing device are not visible during x-ray imaging." to address this potential concern medtronic is including additional information in the instructions for use regarding these issues to further clarify the use of these devices to health care practitioners. the updated instructions for use includes the precautions that will help reduce the potential for clinical consequences when some neurosurgical patties which are designed to be x ray detectable or radiopaque to assist with post-procedural removal in the event of a missing device are not visible during x-ray imaging.

Device

MEROCEL SURGICAL PATTIES
  • Modelo / Serial
    Model Catalog: 300507 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 300506 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 300505 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 300503 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 300501 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04009 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04008 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04007 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04006 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04005 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04004 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04003 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04002 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04001 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 80-04000 (Lot serial: > 10 lot numbers contact mfg); Model Catalog
  • Descripción del producto
    MEROCEL SURGICAL PATTIES;NEURAY SURGICAL PATTIES;NEURAY SURGICAL STRIPS
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Dirección del fabricante
    BRAMPTON
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC