Events

Retiro De Equipo (Recall) de Ethicon Physiomesh Flexible Composite Mesh

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.

¿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-2016-RN-00699-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-30
  • 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-2016-RN-00699-1
  • 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 & johnson medical pty. ltd. (jjm) is issuing a medical device recall, in line with an ethicon initiated worldwide medical device removal, of ethicon physiomesh flexible composite mesh (for laparoscopic use).The product is being removed following an analysis conducted at the request of the ethicon medical safety team of unpublished data from two large independent hernia registries (herniamed german registry and danish hernia database-dhdb). the recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries.
  • Acción
    Johnson & Johnson Medical advises customers to inspect stocks and immediately quarantine any affected units prior to their return. The management of patients who have been treated using ETHICON PHYSIOMESH Composite Mesh will remain at the discretion of the treating health care practitioner. A Hazard alert letter will be sent to Surgeons.

Device

Ethicon Physiomesh Flexible Composite Mesh
  • Modelo / Serial
    Ethicon Physiomesh Flexible Composite MeshAll Product Codes and Lot Numbers affectedARTG Number: 182785
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd