BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLUENCE

    MDR report key: 445513 · Received February 26, 2003

    Report

    Report Number
    2183959-2003-00021
    Event Type
    Injury
    Date Received
    February 26, 2003
    Date of Event
    February 1, 2000
    Report Date
    February 26, 2003
    Manufacturer
    MANUFACTURED FOR INFLUENCE/AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "URINE RETENTION. CYSTOSCOPY REVEALED ELEVATED BLADDER NECK. PRESENTED FOR REVISION OF SLING. GRAFT WAS RIDING UP ON BLADDER NECK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLUENCE TRIANGLE GELATIN-SEALED SLING FTL MANUFACTURED FOR INFLUENCE/AMERICAN MEDICAL SYSTEMS, INC. * 29244/1A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R