BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEFYX SLING SYSTEM

    MDR report key: 1063478 · Received June 20, 2008

    Report

    Report Number
    3005099803-2008-00887
    Event Type
    Injury
    Date Received
    June 20, 2008
    Report Date
    May 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SPECIFIC DEVICE HISTORY RECORD COULD NOT BE CONDUCTED DUE TO THE LOT NUMBER BEING UNKNOWN. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON EACH OF THE 3 LOTS FROM THE SHIP HISTORY SEARCH. NO ISSUES THAT COULD BE ASSOCIATED WITH THIS INCIDENT WERE FOUND. A LOT HISTORY SEARCH WAS PERFORMED ON EACH OF THE 3 LOTS, NO SIMILAR COMPLAINTS WERE FOUND. THERE IS NO EVIDENCE THAT THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE LABELING. THE RISK OF THIS DEFECT IS NOTED WITHIN THE LABELING. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT IN 2007, A PATIENT UNDERWENT A PREFYX PRE-PUBIC SLING PLACEMENT. SOMETIMES POST PROCEDURE, THE MESH ERODED THROUGH THE ANTERIOR WALL OF THE VAGINA AT THE MID-URETHRA. AN ESTROGEN CREAM WAS APPLIED BUT DID NOT HELP. THE PHYSICIAN IS PLANNING TO CLIP THE EXPOSED MESH AND RE-SLING THE PATIENT. PATIENT IS FINE, NO REPORTED DIFFICULTY VOIDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEFYX SLING SYSTEM FTL BOSTON SCIENTIFIC CORPORATION M0068506001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention