BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFYX PPS SYSTEM

    MDR report key: 3120863 · Received May 20, 2013

    Report

    Report Number
    3005099803-2013-03940
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT # 3005099803-2013-03904 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREFYX PPS SYSTEM WAS IMPLANTED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. 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
    221666 PREFYX PPS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - SPENCER UNK335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other POLYFORM SYNTHETIC MESH| PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT