Events

Alerte De Sécurité sur 3M Scotchcast Wet or Dry Cast Padding

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par 3M.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-08-07
  • Date de publication de l'événement
    2013-08-07
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130807b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: 3m scotchcast wet or dry cast padding medical device manufacturer, 3m, has issued a medical device safety alert concerning certain lots of scotchcast wet or dry cast padding. the affected catalogue numbers and lot numbers are provided in the following table:- catalogue numbers lot numbers wdp2 792920, 793090, 793640 & 796078 wdp3 792921, 793098, 793638, 796077 & 798487 wdp4 792922, 793116, 793637, 796079, & 798488 wdp6 792923, 793636, 798489, 799235 & 799236 the manufacturer is conducting a voluntary product recall of selected lots of 3m scotchcast wet or dry cast padding following a determination that the cast padding material does not consistently repel water. lack of repellency may result in prolonged cast dry times after exposure to wet conditions. the manufacturer become aware of this issue through health care provider feedback and confirmed it by internal testing. there is a potential of skin maceration under a cast exhibiting inconsistent repellency characteristics. there have been no reports of patient injury associated this material to date. the manufacturer is advising all affected users that currently at the end user setting the captioned cast padding may be used under dry conditions only until replacement product is available. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 august 2013.

Device

3M Scotchcast Wet or Dry Cast Padding
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: 3M Scotchcast Wet or Dry Cast Padding
  • Manufacturer
    3M

Manufacturer

3M