Convatec Limited 2019-006MA Convex Two-Piece Skin Barriers i.e. Natura
ConvaTec has voluntarily initiated a Field Safety Corrective Action in the form of a Customer Notification for specific product codes and lots of the above-mentioned Ostomy products. ConvaTec has received complaints associated with use of Convex Two-Piece Skin Barriers where the starter hole (stoma hole) is off-centre on product manufactured from February 2017 to September 2018. Specifically, we have had three instances globally where use of an off-centre Convex Two-Piece Skin Barrier led to a stomal cut. These cuts did not require hospitalization and the end-user was able to resolve the issue. The overall risk of injury is low. However, since this risk can be visually detected, we are taking precautionary measures to notify customers of this matter so that the end-user can thoroughly check their product to see if it: a) was manufactured during this period and b) is visually off-centre.
Fabrikant: Convatec Limited
Product: Convex Two-Piece Skin Barriers i.e. Natura
Waarschuwing van de fabrikant
Dit bericht is een waarschuwing van de fabrikant. Na het op de markt brengen van een medisch hulpmiddel is de fabrikant verplicht het hulpmiddel te volgen en waar nodig te verbeteren. Wanneer sprake is van een risico voor de gebruiker moet de fabrikant actie ondernemen. De fabrikant informeert gebruikers en de inspectie over deze actie met een waarschuwing (Field Safety Notice). Zie ook waarschuwingen medische hulpmiddelen. Dit hoort bij het toezicht op medische technologie.