BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTROL PUMP SPHINCTER

    MDR report key: 31954 · Received April 19, 1995

    Report

    Report Number
    31954
    Event Type
    Other
    Date Received
    April 19, 1995
    Date of Event
    December 1, 1994
    Report Date
    March 23, 1995
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT FIRST HAD ARTIFICIAL SPHINCTER PLACED ON 9/27/94. SURGERY WAS REDONE ON 12/1/94 TO REMOVE THE PUMP FROM THE SCROTUM. THERE WAS NOTED TO BE AIR IN THE PUMP AND THE PUMP DID NOT WORK. AT THIS TIME, THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTROL PUMP SPHINCTER Implant CONTROL PUMP SPHINCTER EZY AMERICAN MEDICAL SYSTEMS, INC. AN058 019

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other