BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMYRA MESH (BRANDED AS MOTIFMESH IN THE US)

    MDR report key: 2889413 · Received November 20, 2012

    Report

    Report Number
    3004859928-2012-00034
    Event Type
    Other
    Date Received
    November 20, 2012
    Date of Event
    April 1, 2012
    Report Date
    November 20, 2012
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM PTFE. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT C001631 DID NOT IDENTIFY ANYTHING ATYPICAL WITH THE MANUFACTURE OF THE LOTS THAT MAY POTENTIALLY HAVE CONTRIBUTED TO THE MESH BREAKING OR TEARING IN CLINICAL USE.

    Description of Event or Problem · 1

    PROXY BIOMEDICAL WAS NOTIFIED (B)(6) 2012 VIA EMAIL BY THE OMYRA MESH DISTRIBUTOR IN EUROPE ((B)(6)) THAT THEY HAVE RECEIVED A COMPLAINT FROM A (B)(6) TENDER CUSTOMER FOR OMYRA MESH. OMYRA MESH IS BRANDED AS MOTIFMESH IN THE US. THE EMAIL FROM (B)(6) SPECIFIES THAT 5 DAYS AFTER IMPLANTATION OF THE OMYRA MESH, SURGICAL INTERVENTION WAS REQUIRED AND THE MESH WAS FOUND TO BE "BROKEN IN HALF" WITHIN THE PATIENT. IT WAS ALSO SPECIFIED THAT "THE CLIENT STATES THAT THE RUPTURE ZONE DID NOT COINCIDE WITH THE AREA OF THE FIXATION TACKERS NOR WAS THE MESH PLACED UNDER TENSION." NO INFORMATION REGARDING THE PATIENT, THE PROCEDURE, THE HOSPITAL OR THE PHYSICIAN WAS PROVIDED BY THE HOSPITAL OR BY (B)(6) DESPITE NUMEROUS ATTEMPTS MADE BY PROXY BIOMEDICAL TO OBTAIN FURTHER DETAILS. THE IMPLANT WAS A 20CM X 30CM OMYRA MESH, PART NUMBER 1062030. THE LOT NUMBER PROVIDED WAS C001631. NO OTHER INFORMATION ON THE HOSPITAL OR PATIENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMYRA MESH (BRANDED AS MOTIFMESH IN THE US) MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD. 20 X 30 CM C001631

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK