BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3231259 · Received July 17, 2013

    Report

    Report Number
    2210968-2013-13500
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    July 12, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT AN ABDOMINAL COLPORECTOPEXY FOR A RECTAL PROLAPSE IN 2004 AND MESH WAS IMPLANTED. THE PATIENT STATES THAT SINCE THE SURGERY SHE HAS HAD MULTIPLE AUTOIMMUNE DISEASES. SHE HAS HAD HER THYROID AND APPENDIX REMOVED. THE MESH WAS ADHERED TO THE SACRUM CAUSING CONSTANT BACK PAIN AND HER RECTUM NEEDED TO BE REMOVED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330614 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK QEE834

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention