BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 3893959 · Received June 25, 2014

    Report

    Report Number
    2210968-2014-08189
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 7, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT EXPERIENCED RECURRENT PARAUMBILICAL HERNIA. APPROXIMATELY THREE WEEKS POST-OPERATIVELY, THE PATIENT EXPERIENCED INFECTION WITH PUS FORMATION AND GANGRENE OF THE ABDOMINAL WALL. THE MESH WAS CULTURED TWICE AND NO ORGANISM WAS FOUND. THE PATIENT WAS THEN FIRST DIAGNOSED WITH DIABETES. DEBRIDEMENT AND REMOVAL OF ONLY THE NON-ADHERENT MESH WAS PERFORMED. THE CURRENT PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. TWO MONTHS FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED FEVER AND SEVERE INFECTION. THE WOUND WAS ALMOST TOTALLY OPENED. THE PHYSICIAN OPINES THE EXPOSED PARTS OF THE MESH SEEM SOFTENED IN A STRANGE MANNER AND THERE MAY BE SOME SORT OF IMMUNOLOGICAL REJECTION TO THE MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372141 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention