BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 36110 · Received August 28, 1996

    Report

    Report Number
    MW4001439
    Event Type
    Other
    Date Received
    August 28, 1996
    Date of Event
    July 26, 1996
    Report Date
    August 5, 1996
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD INFECTION WHICH REQUIRED REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant URINARY SPHINCTER EZY AMERICAN MEDICAL SYSTEMS 72401685/7240098/72400162 *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other