Events

Retiro De Equipo (Recall) de 3M Surgical Clipper

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por 3M 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-2018-RN-00151-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-13
  • 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-2018-RN-00151-1
  • 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
    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.”.
  • Acción
    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
  • Modelo / Serial
    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
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    DHTGA