BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFYX PPS SYSTEM

    MDR report key: 2211786 · Received August 15, 2011

    Report

    Report Number
    3005099803-2011-02792
    Event Type
    Injury
    Date Received
    August 15, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME CASE AND PATIENT AS MFR REPORT # 3005099803-2011-02717. THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREFYX PREPUBIC SLING SYSTEM WAS USED DURING A VAGINAL RECONSTRUCTION PROCEDURE ON (B)(6), 2008. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH MESH EROSION IN (B)(6) 2009. ON THIS DATE, THE PHYSICIAN ATTEMPTED TO TRIM PARTS OF THE MESH THAT WERE PROTRUDING THROUGH THE VAGINAL WALL. ON (B)(6), 2009, THE PATIENT HAD ANOTHER SURGERY FOR STRESS URINARY INCONTINENCE AND CHRONIC PAIN (EXACT TYPE UNKNOWN). ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREFYX PPS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PINNACLE PELVIC FLOOR REPAIR KIT