BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLUENCE

    MDR report key: 445460 · Received February 26, 2003

    Report

    Report Number
    2183959-2003-00012
    Event Type
    Injury
    Date Received
    February 26, 2003
    Date of Event
    January 18, 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

    "PATIENT CONTINUED TO HAVE CONCERNS THAT THE SLING WAS NO LONGER IN PLACE. EXAMINATION REVEALED GRAFT EROSION. IN SURGERY, GRAFT WAS REMOVED, ABSCESS DRAINED."

    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. * 28989/4B

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R