BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2103612 · Received May 26, 2011

    Report

    Report Number
    3005099803-2011-01735
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MONTHS AFTER IMPLANTATION OF AN UPHOLD VAGINAL SUPPORT SYSTEM IN AN ANTERIOR REPAIR PROCEDURE VIA A VERTICAL INCISION, THE PATIENT PRESENTED WITH MESH EROSION ON THE APICAL CORNER. THE PHYSICIAN DID NOT TREAT THE EROSION AND DOES NOT PLAN ANY INTERVENTION AT THIS TIME. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050 1ML0120102

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other