BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN MEDICAL SYSTEMS "MONARC"

    MDR report key: 475428 · Received August 1, 2003

    Report

    Report Number
    475428
    Event Type
    Malfunction
    Date Received
    August 1, 2003
    Date of Event
    July 30, 2003
    Report Date
    August 1, 2003
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INSERTION DEVICE MALFUNCTIONED WHILE ATTEMPTING TO GET READY TO USE BY DOCTOR. DEVICE NEVER TOUCHED PATIENT. ALTERNATIVE METHOD USED TO COMPLETE SURGERY. AMS COMPANY RECALLED THE DEVICES WITH SPECIFIC LOT NUMBERS THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS "MONARC" VAGINAL SLING SYSTEM FTL AMERICAN MEDICAL SYSTEMS * 372128030

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other