BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIFESH SOFT TISSUE PATCH (OMYRA IN EUROPE)

    MDR report key: 3877681 · Received May 27, 2014

    Report

    Report Number
    3004859928-2014-00053
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 23, 2014
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Product Code
    FTL
    PMA / PMN Number
    K052100
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. CONCLUSION - INCONCLUSIVE, INVESTIGATION ON-GOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM (B)(4). COMPLICATIONS SUCH AS ADHESIONS ARE A DOCUMENTED RISK ASSOCIATED WITH THE MOTIFMESH DEVICE - REF DESIGN FMEA AND MOTIFMESH PRODUCT INSERT (INSTRUCTIONS FOR USE).

    Description of Event or Problem · 1

    PROXY BIOMEDICAL WAS NOTIFIED ON (B)(4) 2014 VIA (B)(4) BY THE OMYRA MESH DISTRIBUTOR ((B)(4)) THAT THEY HAVE RECEIVED A COMPLAINT REGARDING A OMYRA MESH PRODUCT (PART # 1062030, LOT # C001800). THE COMPLAINT WAS REPORTED TO (B)(4) BY DR (B)(6) - (B)(6) HOSPITAL, (B)(6). FOLLOWING IMPLANT OF OMYRA MESH, THE PT DEVELOPED ADHESIONS BETWEEN THE BOWEL AND THE MESH WHICH LED TO OBSTRUCTION OF THE BOWEL. THE PT MADE A FUL RECOVERY. NOTE: OMYRA MESH - DISTRIBUTED IN (B)(4) BY (B)(4) , IS ALSO BRANDED AS MOTIFMESH IN THE USA BY PROXY BIOMEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310822 MOTIFESH SOFT TISSUE PATCH (OMYRA IN EUROPE) MESH, SURGICAL, POLYMERIC FTL PROXY BIOMEDICAL LTD. 20X30CM C001800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention