Events

Safety Alert for PERMA-HAND Silk Suture

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

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
    2017-01-27
  • Event Date Posted
    2017-01-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170127.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: ethicon perma-hand silk suture medical device manufacturer, ethicon, has issued a medical device safety alert concerning its perma-hand silk suture (also referred to as mersilk silk suture) [product code: w584; lot number: jcq247]. the manufacturer has initiated a voluntary medical device removal of one lot of ethicon perma-hand silk suture. product from the affected lot was found to have an open sterile packaging seal which could compromise device sterility. at this time, the manufacturer has received no reports of adverse events for this issue. according to the manufacturer’s health hazard evaluation, there is an extremely rare probability of adverse consequences in patients in whom these sutures were used. healthcare practitioners that have treated patients using product from the affected lots should continue to follow those patients in the usual manner. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 january 2017.

Device

PERMA-HAND Silk Suture
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: ETHICON PERMA-HAND Silk Suture
  • Manufacturer
    ETHICON

Manufacturer

ETHICON