BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC SLING SYSTEM

    MDR report key: 1972262 · Received January 20, 2011

    Report

    Report Number
    2183959-2011-00049
    Event Type
    Injury
    Date Received
    January 20, 2011
    Report Date
    January 13, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    INFO INDICATES A MONARC SLING WAS IMPLANTED IN A PT WITH URINARY STRESS INCONTINENCE AND OVERACTIVE BLADDER. SHE DID NOT UNDERSTAND THE MONARC WAS A TREATMENT FOR ONLY STRESS INCONTINENCE. PATIENT WOULD HAVE DECLINED THE IMPLANT IF SHE KNEW IT DID NOT TREAT OVERACTIVE BLADDER. SHE REPORTS THE MONARC SLING MADE HER OVERACTIVE BLADDER ISSUE WORSE DUE TO INCREASED AMOUNT OF URINARY LEAKAGE AND INCREASED URGE INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARC SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability