Events

Safety Alert for vivano med foam abdominal kit st p3

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

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
    2017-03-13
  • Event Date Posted
    2017-03-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170313.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: paul hartmann vivano med foam abdominal kit st p3 medical device manufacturer, paul hartmann ag, has issued a medical device safety alert concerning its vivano med foam abdominal kit st p3. the affected device’s product reference number is 409 721/2 and the lot number is 408584-1902001. vivano med foam abdominal kits are wound dressing sets for the negative pressure wound care in conjunction with a vivano tec negative pressure therapy system. these include in addition to the hydrophobic pu foam dressing a pe organ protection layer. the organ protection layer is a round, micro-perforated polyethylene film (ø 65 cm) with 6 welded application pockets, which are designed to facilitate the introduction of this organ protection layer between the abdominal wall and the internal organs. in the manufacturer’s internal routine controls, a deviation in the manufacturing process for the above mentioned organ protection layer has been identified. this could lead to a lower stability of the weld seams, which connects the application pockets to the pe organ protection layer. an increased mechanical load could lead to a potential risk that one of the applicator pockets could be detached. the manufacturer advises users to examine their inventory, not to use the affected products and return them to the manufacturer. 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 13 march 2017.

Device

vivano med foam abdominal kit st p3
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Paul Hartmann Vivano Med Foam Abdominal Kit st P3
  • Manufacturer
    Paul Hartmann AG

Manufacturer

Paul Hartmann AG