Events

Rappel de ENCORE STANDING AID

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ARJO CANADA INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    55894
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2012-05-24
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Arjohuntleigh has been made aware of a serious incident. during exercise a standing and raising aid was used to support a patient to stand. the knee pad had been removed. however the support bracket holding the proactive knee pad support had not been removed as described in the instructions for use manual. this results in a vertical square section end of the metal support bracket becoming exposed and patients may fall onto the metal bracket causing severe trauma. this accident could have been avoided if the support bracket assembly had been removed with the proactive knee pad support. arjohuntleigh would like to remind users that the entire knee pad and support bracket assembly must be removed when required to do so for exercise.

Device

ENCORE STANDING AID
  • Modèle / numéro de série
    Model Catalog: KKB5040-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5042-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5022-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5020-21US (Lot serial: >100 numbers contact mfg); Model Catalog: HEP1001-US (Lot serial: >100 numbers contact mfg); Model Catalog: HEP0001-US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5060-23US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5060-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5080-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5080-23US (Lot serial: >100 numbers contact mfg)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    ENCORE STANDING AID
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

ARJO CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    HC