BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 3242430 · Received July 23, 2013

    Report

    Report Number
    3005099803-2013-07690
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO TWO OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT # 3005099803-2013-06386 PERTAINS TO THE OTHER DEVICE.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PFR KIT - PINNACLE, ANTERIOR APICAL WAS IMPLANTED (B)(6), 2010.ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN DUE TO MESH EROSION AND INCURRED ADDITIONAL MEDICAL TREATMENT AND PROCEDURES. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344310 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068317050 0ML9021701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OBTRYX HALO SINGLE SYSTEM DEVICE