Events

Safety Alert for 3M Universal Electrosurgical Pads

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by 3M.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-03-20
  • Event Date Posted
    2017-03-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170320a.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: 3M Universal Electrosurgical Pads
  • Manufacturer
    3M

Manufacturer

3M