Medical device manufacturer, ConvaTec, has issued a medical device safety alert concerning its DuoDERM Extra Thin and DuoDERM CGF. The affected devices in Hong Kong include the following:
| ICC# | Lot# |
|---|---|
| 187957 | 9J02859, |
| 187955 | 9L01731, 9H01234, 9M01779, |
| 187660 | 9B02984Y, 9K05775, 0A03460, 9A04124Y |
The manufacturer has discovered a potential product packaging issue affecting batches of the above-mentioned products. According to the manufacturer, an increasing trend of complaints related to open seals, tears and rips in the primary packaging was reported in 2020 for DuoDERM Extra Thin and DuoDERM CGF products families. The dressing may be opened or the product may be sealed within the seam of the primary package. As a result, there is potential for a breach in the sterile barrier resulting in a possible risk of infection, delayed wound healing and increased scarring.
The manufacturer is instructing affected users to dispose the affected devices.
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 4 Aug 2021