Events

Safety Alert for 3M Scotchcast Wet or Dry Cast Padding

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
    2013-08-07
  • Event Date Posted
    2013-08-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130807b.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 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
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: 3M Scotchcast Wet or Dry Cast Padding
  • Manufacturer
    3M

Manufacturer

3M