BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEM

    MDR report key: 1217578 · Received October 30, 2008

    Report

    Report Number
    1217578
    Event Type
    Injury
    Date Received
    October 30, 2008
    Date of Event
    May 5, 2008
    Report Date
    October 29, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEM
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGICAL MESH AND SURGICAL SLING HAD TO BE EXPLANTED AFTER PT DEVELOPED ABSCESS AND SEVERE INFECTION. REQUIRED TRANSFER TO A HIGHER LEVEL OF CARE. PT WAS CRITICALLY ILL AND IS NOW DOING WELL. PT BROUGHT THIS TO MY ATTENTION THIS IS WHY REPORT IS LATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEM PERIGEE AND BLADE SYSTEM URETHRAL SLING FTL AMERICAN MEDICAL SYSTEM BLADE SYSTEM 59795 1009
    2 AMERICAN MEDICAL SYSTEM PERIGEE AND BLADE SYSTEM PELVIC MESH FTL AMERICAN MEDICAL SYSTEM BLADE SYSTEM 542221029

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R