Medical device manufacturer, ConvaTec, issued a medical device safety alert concerning its AQUACEL FOAM ADH 10X10CM(1X10) EUR [Reference Number: 420680; Lot Number: 1E01138].
According to the manufacturer, an error during an update to the Instructions For Use (IFU) has resulted in the German translation of the instructions being left out of the IFU for the above-mentioned lot number. Absence of German language from the IFU could potentially lead to the dressing being misused. This may include using on an incorrect wound type, not changing the dressing frequently enough, incorrect disposal, and lack of information on contraindications/warnings/precautions. The immediate consequence maybe delayed wound healing or reversal of wound progress. The manufacturer has executed the required actions immediately to secure this issue.
The manufacturer is instructing affected users to retain the Field Safety Notice for information. Affected users are advised that Instructions for use can also be obtained from the ConvaTec website. Product can continue to be used in accordance with the instructions within the IFU.
According to the local supplier, the affected devices are NOT distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Dec 2021