BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 3241665 · Received July 22, 2013

    Report

    Report Number
    3005099803-2013-06979
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN). ACCORDING TO THE PHYSICIAN;S OFFICE, THERE WERE NO COMPLICATIONS REPORTED POST-PROCEDURE. ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340352 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other