BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 113643 · Received August 14, 1997

    Report

    Report Number
    2126328-1997-03625
    Event Type
    Injury
    Date Received
    August 14, 1997
    Date of Event
    July 10, 1997
    Report Date
    August 14, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUFF PERFORMED WITHIN SPECIFICATIONS. PUMP PERFORMED WITHIN SPECIFICATIONS. BALLOON PERFORMED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED 2/13/1998 INDICATES "LEAK IN BALLOON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EZY AMERICAN MEDICAL SYSTEMS, INC. 800 CC695 006,CC428 003,CB127 007

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R