Medical device manufacturer, ConvaTec, has issued a medical device safety alert concerning its Convex Two-Piece Skin Barriers, the products are identified as follow:

• Product: A) SURFIT NATURA WFR CVX 16/45MM (1X10PK)US;
  B) SURFIT NATURA WFR CVX 19/45MM (1X10PK)US;
  C) SURFIT NATURA WFR CVX 22/45MM (1X10PK)US;
  D) SURFIT NATURA WFR CVX 25/45MM (1X10PK)US;
  E) SURFIT NATURA WFR CVX 28/45MM (1X10PK)US;
  F) SURFIT NATURA WFR CVX 32/45MM (1X10PK)US;
  G) SURFIT NATURA WFR CVX 35/45MM (1X10PK)US
• Product Code: A) 413178; B) 413179; C) 413180; D) 413181; E) 413182; F) 413183; G) 413184
• Lot Number: A) 7E02314; B) 8A00731; C) 7C01423, 7K00522, 7K05910, 7M02816; D) 7F01780, 7G04454, 7K03820, 7M03980, 8B00893, 8H03658; E) 8F01050; F) 8A02999, 8B05002, 8D05105; G) 7J05042

The manufacturer 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, the manufacturer 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.

Since this risk can be visually detected, the manufacturer is taking precautionary measures to notify customers of this matter so that the end-user can thoroughly check their product to see if the product is manufactured during this period and is visually off-centre.

According to the manufacturer, product replacement is on-going.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 3 September 2019