BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFYX PPS SYSTEM

    MDR report key: 3191380 · Received June 26, 2013

    Report

    Report Number
    3005099803-2013-05199
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 6, 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 (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN¿S OFFICE, THE PATIENT WAS LAST SEEN (B)(6) 2011, AND PRESENTED WITH URINARY FREQUENCY. A URINE CULTURE WAS TAKEN AND THE RESULTS CAME BACK POSITIVE FOR AN INFECTION. ANTIBIOTICS WERE PRESCRIBED. THE TYPE AND DOSAGE ARE UNKNOWN. 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
    290882 PREFYX PPS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - SPENCER UNK335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention