BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 77130 · Received March 14, 1997

    Report

    Report Number
    2126328-1997-00987
    Event Type
    Injury
    Date Received
    March 14, 1997
    Date of Event
    February 10, 1997
    Report Date
    March 14, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 4/14/97 INDICATES REASON AS MALFUNCTIONING SPHINCTER CUFF, BALLOON, AND CONNECTORS, REFER TO ACCESS #1010981.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EZY AMERICAN MEDICAL SYSTEMS, INC. 800 3853H 008,3230R 001

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R