BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 220586 · Received April 23, 1999

    Report

    Report Number
    MW1016191
    Event Type
    Malfunction
    Date Received
    April 23, 1999
    Date of Event
    March 24, 1999
    Report Date
    April 14, 1999
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD INSERTION OF AMS CX PROSTHESIS ON 9/23/98. HE HAS BEEN UNABLE TO ADEQUATELY INFLATE AND DEFLATE PROSTHESIS. ON 3/24/99, PUMP REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS Implant PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC. AMS-CX *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR