Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Synovis Life Technologies, Inc. (Baxter International Inc.) PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch [Product Code: PC0404N, PC0608N, PC0814N, PC1016N. PC1225N, PC0404SN, PC0608SN, PC0814SN, PC1016SN; Serial/Lot numbers: All within expiry] [HKMD Number: 220164].
According to the MHRA, on March 7, 2022, the manufacturer implemented labeling changes on CE-marked Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch products including removal of the indications for abdominal wall defect and hernia (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical) repair from the Instruction for Use (IFU).
The indications on the labeling changed from:
To:
The manufacturer has since received seven complaints reporting infection/abscess, all of which were received from one and the same clinic in Italy. Six of the complaints were determined to be correlated to “off-label” use of Peri-Guard Repair Patch (multiple product codes) in abdominal surgery.
According to the manufacturer, the change was not driven by any known safety concerns. However, there is a lack of clinical data supporting the safety and effectiveness of the Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch for abdominal wall and hernia defect repair. As such, these indications are no longer approved for CE-Marked Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch and should be considered “off-label” in the European Union.
For further information, please visit
https://mhra-gov.filecamp.com/s/d/txvCgTte62N7Hvig
https://mhra-gov.filecamp.com/s/d/3YZNXmFXgeFHlmzm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Mar 2024