Events

Safety Alert for Wound Management Ltd. TOPPER Xtra Absorbent Dressing Pads

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

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
    2014-07-17
  • Event Date Posted
    2014-07-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140717b.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: systagenix wound management ltd. topper xtra absorbent dressing pads medical device manufacturer, systagenix wound management ltd., has issued a field safety notice (fsn) concerning topper xtra absorbent dressing pads (product code: m11121n, m11131, m11141, p55263, p55264 and p55255). the manufacturer has become aware that the sterility of some product may be compromised due to small holes in the bottom layer of the primary pouch; its subsequent use may therefore pose a potential risk of localised infection. the manufacturer advises users to immediately segregate and discontinue use of the affected products. clinicians should immediately discontinue use of the affected products, and monitor any patients who were using, or have recently used, any of the affected product for signs of localised infection, including heat, pain, redness or swelling around the wound or increased wound drainage. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 17 jul 2014.

Device

Wound Management Ltd. TOPPER Xtra Absorbent Dressing Pads
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Systagenix Wound Management Ltd. TOPPER Xtra Absorbent Dressing Pads
  • Manufacturer
    Systagenix Wound Management Ltd.

Manufacturer

Systagenix Wound Management Ltd.