BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1080715 · Received July 18, 2008

    Report

    Report Number
    2210968-2008-00567
    Event Type
    Injury
    Date Received
    July 18, 2008
    Date of Event
    May 25, 2006
    Report Date
    February 1, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED, AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A RETROPUBIC SLING PROCEDURE AND A PELVIC FLOOR REPAIR IN 2006. THE SURGEON ASSESSED THE PT ABOUT 6 DAYS LATER, AND TREATED HER FOR PAIN AND SWELLING UNTIL THE NEXT 5 DAYS. THE SURGEON ASSESSED THE PT ABOUT 2 DAYS LATER, AND SAW AN IMPROVEMENT. THE SURGEON DID NOT HEAR FROM THE PT AGAIN UNTIL APPROXIMATELY 3 MONTHS LATER, WHEN THE PT WAS EXPERIENCING PAIN, SOME BURNING ON MICTURITION, AND A DEGREE OF VAGINAL DISCOMFORT AND CONSTIPATION. ON AN UNK DATE, THE PT REPORTEDLY EXPERIENCED NECROTIZING FASCIITIS AND A MESH EROSION WITH VAGINAL BLEEDING. APPROX THREE MONTHS AFTER THE INITIAL PROCEDURE, A SECOND SURGEON PERFORMED A PROCEDURE TO REMOVE FOUR CM OF MESH AND TO CLOSE THE EROSION. CURRENTLY, THE PT REPORTS LOSS OF BLADDER CONTROL AND LOSS OF RECTAL FUNCTION AND REQUIRES LAXATIVES DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention