Events

Rappel de 3M Surgical Clipper

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par 3M Australia Pty Ltd.

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
    RC-2018-RN-00151-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00151-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    3m australia is notifying all users of an added product warning, stressing the importance of following proper clipper charging practices as documented in the instructions for use. current charging instructions recommend leaving the clipper body in the drop- in charger in between uses.Failure to follow proper charging practices can result in lithium-ion battery degradation, characterised by excessive heat during operation or failure to properly charge. in rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy which may potentially result in patient/user burns, or electrical shocks. there have been three reported instances overseas where users have experienced electric shocks.3m is adding the following product warning to emphasise the importance of proper charging practices: “warning: to avoid potential battery degradation, charge the clipper after each use and store in the drop-in charger stand when not in use.”.
  • Action
    3M is advising users to inspect any devices, and discard any that do not hold charge or is uncomfortably hot to touch during use. Affected devices will be replaced by 3M. Unaffected devices are to be stored in the drop in charger stand when not in use.

Device

3M Surgical Clipper
  • Modèle / numéro de série
    3M Surgical ClipperModel Number: Professional 9681All lot numbers affectedARTG Number: 101095(3M Australia - Clipper, hair, electric)
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    DHTGA