BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFYX PPS® SYSTEM

    MDR report key: 3071210 · Received April 22, 2013

    Report

    Report Number
    3005099803-2013-02562
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    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 EROSION AND EXTRUSION OF THE MESH, CAUSING SEVERE PERSISTENT PAIN, NERVE DAMAGE, WEIGHT GAIN, AND AN INABILITY TO PERFORM HOUSEHOLD FUNCTIONS AND SEXUAL RELATIONS. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    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 EROSION AND EXTRUSION OF THE MESH, CAUSING SEVERE PERSISTENT PAIN, NERVE DAMAGE, WEIGHT GAIN, AND AN INABILITY TO PERFORM HOUSEHOLD FUNCTIONS AND SEXUAL RELATIONS. 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
    171697 PREFYX PPS® SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - SPENCER M0068506001 12599663

    Patients

    Seq Age Sex Outcome Treatment
    1 Other