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