BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALE SLING SYSTEM

    MDR report key: 1962545 · Received January 7, 2011

    Report

    Report Number
    2183959-2011-00037
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 17, 2010
    Report Date
    December 14, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AUS DEVICE COMPLAINT WILL BE REPORTED VIA THE ASR SYSTEM IDENTIFIED AS (B)(4) SHOULD ADD'L INFO BECOMES AVAILABLE REGARDING THIS REVISION SURGERY, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2009 AN AUS DEVICE WAS IMPLANTED IN THIS PT THAT HAS HAD A PREVIOUS PROSTATECTOMY PROCEDURE. INFO REC'D INDICATES A SLING SYSTEM WAS PLACED SOMETIME AFTER THE AUS DEVICE WAS IMPLANTED, TYPE OF AMS SLING IMPLANTED WAS NOT INDICATED. ON (B)(6) 2010, THE PT HAD THE ENTIRE AUS DEVICE AND MOST OF THE SLING SYSTEM REMOVED DUE TO THE SLING BECOMING INFECTED. AMS HAS REQUESTED ADD'L INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R