Events

Retiro De Equipo (Recall) de Sciatic Nerve Retractors

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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-2018-RN-00334-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-18
  • 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-2018-RN-00334-1
  • 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
    Johnson and johnson has identified the potential for micropores to form on the hollow handle of the sciatic nerve retractor. the pores may increase in size, allowing fluid to enter the hollow handle. discoloration and moisture were identified within the packaging of the affected lots of sciatic nerve retractors indicating that these pores may be present in the affected devices.Even with diligent reprocessing/sterilisation of the retractor, subsequent patients may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use.
  • Acción
    Johnson and Johnson are advising users to inspect stock and return any affected product as soon as possible.

Device

Sciatic Nerve Retractors
  • Modelo / Serial
    Sciatic Nerve Retractors Part Numbers: 03.100.013, 03.100.014Lot Numbers: T140390, T140675, T140677 ,T145819, T140566, T140673, T151369ARTG Number: 296161Johnson & Johnson Medical t/a DePuy Synthes - Wound retractor, intermediate/deep
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes