BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 1910182 · Received November 18, 2010

    Report

    Report Number
    2183959-2010-00428
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    June 2, 2010
    Report Date
    July 14, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT WAS IMPLANTED WITH AN ADVANCE MALE SLING. THE PHYSICIAN REPORTED VEIN BLEEDING DURING ANCILLARY PATH FROM NEEDLE PASSAGE. THE EVENT WAS INDICATED AS DEVICE RELATED. THE EVENT WAS RESOLVED ON (B)(6) 2010 W/O ANY MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE MALE SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 72404224

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other