Events

Retiro De Equipo (Recall) de PenEvac

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por I C Medical Inc.

¿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
    21266
  • Fecha de inicio del evento
    2017-04-04
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Diploma Healthcare Group Ltd trading as Big Green Surgical New Zealand Ltd, Bendall and Cant, Level 7, Southern Cross Building, Cnr High & Victoria Streets, Auckland 1140
  • Causa
    Reports have been received that the penevac diathermy pen has had instances of self-activation, which can potentially lead to patient and staff injury., phase 2. the manufacturer is issuing this safety alert to remind users of the importance of following the instructions for use to ensure safe use of the penevac1 electrocautery pencils.
  • Acción
    Product to be returned to supplier

Device

PenEvac
  • Modelo / Serial
    Model: , Affected: Lot#6406, Lot#6384 and 6391
  • Manufacturer
    I C Medical Inc

Manufacturer

I C Medical Inc