Events

Retiro De Equipo (Recall) de SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast biopsy sites)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bard 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-2016-RN-01314-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-06
  • 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-01314-1
  • 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
    It has been identified that the product code / lot number combination for a single lot of the device may have an incorrect instruction for use (ifu) containing a table in the description section that misidentifies the wireform and material (titanium and stainless steel). all other product labelling, including outer box and inner packaging, correctly identify the product.The potential exists that a user might inadvertently use a senomark ultracor mri 14 gauge tissue marker of the wrong material in a patient with known hypersensitivity to titanium.
  • Acción
    Bard is providing users with instructions for use that correctly identify the wireform and material. The product can be continued to be used. This action has been closed-out on 17/05/2017.

Device

SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast bio...
  • Modelo / Serial
    SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast biopsy sites)Product code: SMUCMRI14GTLot number: VT15M0543ARTG number: 160027
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd