BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFYX PPS SYSTEM

    MDR report key: 2122883 · Received June 14, 2011

    Report

    Report Number
    3005099803-2011-02125
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREFYX PREPUBIC SLING SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, THE PATIENT SUFFERED EROSION, PAIN AND INFECTIONS. THE EXACT DATE OF ONSET FOR EACH IS UNKNOWN. ALL OTHER EVENT DETAILS ARE UNKNOWN. SHOULD ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 Other