Events

Retiro De Equipo (Recall) de AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used for administration of medication Duodopa (Levodopa Carbidopa) Intestinal Gel)AbbVie PEG 15 R

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abbvie 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-00619-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-05-17
  • 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-00619-1
  • 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
    Abbvie has identified the potential for missing components and / or duplicate components in the abbvie peg 15 r and abbvie j intestinal tube 9 fr for peg 15 fr kits. the reported events of missing components have not been associated with any reports to abbvie of related serious injury and it is unlikely for the missing components to pose any significant safety risk.
  • Acción
    AbbVie is advising users to inspect the kits using the product’s Instructions for Use, product description section to ensure all components are present before proceeding with implantation. Any missing components are to be reported to AbbVie, including details of the device lot number, and the kit returned to AbbVie. AbbVie will provide replacement kits if there are missing components.

Device

AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used ...
  • Modelo / Serial
    AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used for administration of medication Duodopa (Levodopa Carbidopa) Intestinal Gel)AbbVie PEG 15 R Product Code: 62941-001AbbVie J Intestinal Tube 9 FR for PEG 15 FR Product Code: 62943-001All lots may be affected.ARTG Numbers: 223443 and 223444
  • Manufacturer
    Abbvie Pty Ltd

Manufacturer

Abbvie Pty Ltd