BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INVANCE MALE SLING SYSTEM

    MDR report key: 3791803 · Received May 6, 2014

    Report

    Report Number
    2183959-2014-00147
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    December 4, 2013
    Report Date
    April 17, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    HWC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HIS INVANCE REMOVED DUE TO INFECTION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272486 AMS INVANCE MALE SLING SYSTEM SCREW, FIXATION, BONE HWC AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R