BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 1060637 · Received June 13, 2008

    Report

    Report Number
    2210968-2008-00439
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    August 6, 2001
    Report Date
    May 16, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE CAUSAL RELATIONSHIP BETWEEN THE REPORT OF A NEW HERNIA AND THE DEVICE IS NOT KNOWN. A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PT UNDERWENT A RIGHT INGUINAL HERNIA REPAIR WITH MESH IMPLANT. THE PT PRESENTED SEVEN MONTHS LATER WITH INDICATIONS OF A BULGE AT THE OPERATIVE SITE. THE SURGEON RECOMMENDED A RETURN TO SURGERY AT THAT TIME, HOWEVER, THE PT HAS NOT RETURNED FOR ANY FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA PEJ311

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention