BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1221212 · Received November 5, 2008

    Report

    Report Number
    3005099803-2008-06065
    Event Type
    Injury
    Date Received
    November 5, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PINNACLE PELVIC FLOOR REPAIR KIT IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE COULD NOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISCARDED SUBSEQUENT TO USE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE CLINICIAN WAS PERFORMING AN ANTERIOR FLOOR REPAIR PROCEDURE ON A FEMALE PATIENT (AGE AND WEIGHT UNKNOWN) USING A PINNACLE PELVIC FLOOR REPAIR KIT (DATE OF PROCEDURE UNKNOWN). DURING THIS PROCEDURE, THE BULLET DETACHED FROM THE SUTURE. THERE WAS NO INDICATION FROM THE COMPLAINANT OF ANY ADVERSE AFFECT TO THE PATIENT, AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KIT FTM BOSTON SCIENTIFIC CORPORATION M0068317050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other