BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM

    MDR report key: 1241606 · Received November 20, 2008

    Report

    Report Number
    2210968-2008-01151
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECURRENT HERNIA, NOT LABELED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT UNDERWENT A RIGHT INGUINAL HERNIA REPAIR WITH MESH IMPLANT IN 2008. THE PT DEVELOPED A SUDDEN RIGHT GROIN PAIN WHILE DOING SOME YARDWORK 1-2 MONTHS FOLLOWING THE PROCEDURE. THE PT WAS EXAMINED AND FOUND TO HAVE A RECURRENT RIGHT INGUINAL HERNIA. THE SURGEON ALSO OBSERVED THAT THE PT HAD A HARD "LUMP" IN HIS RIGHT LOWER QUADRANT ABDOMINAL WALL THAT WAS SEPARATE FROM THE RECURRENT HERNIA. THE PT WAS RETURNED TO SURGERY FOR REPAIR. THE SURGEON OBSERVED THAT THE MESH FRACTURED IN SUCH A MANNER THAT THE UNDERLAY PORTION WAS NO LONGER CONNECTED TO THE OVERLAY PORTION OF THE MESH. THE UNDERLAY PORTION OF THE DEVICE REPORTEDLY MIGRATED SUPERIOR AND LATERAL TO THE INGUINAL RING AND COULD NOT BE EXPLANTED UNDER LOCAL ANESTHESIA. PT IS RECOVERING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE HERNIA SYSTEM MESH, SURGICAL FTL ETHICON, INC. NA 19170-01

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention