BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 3944875 · Received July 18, 2014

    Report

    Report Number
    3005099803-2014-02582
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE PELVIC FLOOR REPAIR KIT WAS USED DURING A POSTERIOR PROLAPSE REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT IMPLANTATION WITHOUT INCIDENT. HOWEVER, A SMALL RECTAL EROSION OCCURRED POST OPERATIVELY. THE PHYSICIAN PLANS TO PERFORM AN ADDITIONAL PROCEDURE AT A FUTURE DATE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421289 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068317100

    Patients

    Seq Age Sex Outcome Treatment
    1