Events

Alerte De Sécurité sur 3M Universal Electrosurgical Pads

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
    2017-03-20
  • Date de publication de l'événement
    2017-03-20
  • 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_20170320a.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 universal electrosurgical pads boston scientific has issued a medical device safety alert concerning 3m universal electrosurgical pads [sku: sgp-082-100, sgp-080-40; lot number: 2019-02dt, 2019-03du, 2019-02db; expiration date range: 1 feb 2019 to 1 mar 2019], manufactured by 3m. this recall follows confirmation of a single user report of an unintended material (process liner) in the product. the presence of a process liner may prevent or impede the safe return of electrosurgical current following electrosurgical unit (esu) activation. this defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body due to increased impedance at the pad application site. this removal affects only the lots listed in this notification. further distribution or use of any remaining product affected by this action should cease immediately. according to the local supplier (boston scientific), the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 march 2017.

Device

3M Universal Electrosurgical Pads
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: 3M Universal Electrosurgical Pads
  • Manufacturer
    3M

Manufacturer

3M