Events

Retiro De Equipo (Recall) de Covidien Devon Light Glove (included in multiple Procedure Packs)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medline International Two Australia Pty 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
    RC-2017-RN-00064-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00064-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Customers have reported that on rare occasions, the devon light glove may split upon application to the devon light handle adapter. some of the reported splits resulted from difficult application of the light glove to the handle adapter. more recently, clinicians have reported finding splits in the light glove following surgery completion, where no difficulty in application of the light glove was encountered or finding splits directly out of the package. a split in the light glove causes a breach in the sterile field and can increase the potential for infection. there have been two reports in which splits were found at the conclusion of surgery.
  • Acción
    Medline is advising users to remove and discard the Covidien Light Glove from the procedure pack at the time of surgery preparation.

Device

Covidien Devon Light Glove (included in multiple Procedure Packs)
  • Modelo / Serial
    Covidien Devon Light Glove (included in multiple Procedure Packs)Multiple Product Codes ARTG Number for the Light Glove itself: 186761ARTG Numbers for the affected Procedure Packs containing the Light Glove: 140059, 136870, 137395, 140054 and 140058
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd