BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIFMESH SOFT TISSUE PATCH (OMYRA MESH)

    MDR report key: 3536452 · Received October 25, 2013

    Report

    Report Number
    3004859928-2013-00201
    Event Type
    Injury
    Date Received
    October 25, 2013
    Date of Event
    August 14, 2013
    Report Date
    October 23, 2013
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Product Code
    FTL
    PMA / PMN Number
    K052100
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS A SYNTHETIC DEVICE MADE FORM PTFE. COMPLICATIONS SUCH AS FISTULA FORMATION ARE A DOCUMENTED RISK ASSOCIATED WITH THE MOTIFMESH DEVICE - REFERENCE DESIGN (B)(4) AND MOTIFMESH PRODUCT INSERT (INSTRUCTIONS FOR USE).

    Description of Event or Problem · 1

    PROXY BIOMEDICAL WAS NOTIFIED ON THE (B)(6) 2013, VIA EMAIL BY THE (B)(4) DISTRIBUTOR, THAT THEY HAVE RECEIVED A COMPLAINT REGARDING A OMYRA MESH PRODUCT (PART # 1061515, LOT # C001662). THE COMPLAINT WAS REPORTED TO B. BRAUN BY (B)(6). FOLLOWING IMPLANT OF OYMRA MESH, THE PT DEVELOPED A COLOCUTANEOUS FISTULA AND RE-INTERVENTION SURGERY WAS REQUIRED. THE PT MADE A FULL RECOVERY. NOTE: OMYRA MESH - DISTRIBUTED IN EUROPE BY (B)(4), IS BRANDED AS MOTIFMESH BY PROXY BIOMEDICAL IN THE USA. THE COMPLAINT CONTAINS DETAILS OF A PT WHO UNDERWENT SURGERY TO CORRECT AN INCISIONAL HERNIA LOCATED THE LEFT MIDDLE-ABDOMINAL AREA. AN OMYRA 15X15CM MESH WAS IMPLANTED ON THE (B)(6) 2013 AND FIXED IN PLACED USING BBRAUN PREMILENE CENTRAL SUTURE USP 1 AND 25 POLYDIOXANONE (PDS) STAPLER CLIPS. THE PT DEVELOPED A COLOCUTANEOUS FISTULA (AN ABNORMAL COMMUNICATION BETWEEN THE LARGE BOWEL AND THE SKIN). RE-INTERVENTION SURGERY TOOK PLACE ON THE (B)(6) 2013; TWO MONTHS AND ONE WEEK AFTER IMPLANTATION. NO DETAILS ON THE RE-INTERVENTION SURGERY HAVE BEEN PROVIDED. THE PT MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549399 MOTIFMESH SOFT TISSUE PATCH (OMYRA MESH) MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD. 1061515 C001662

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention