BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 96916 · Received June 5, 1997

    Report

    Report Number
    96916
    Event Type
    Injury
    Date Received
    June 5, 1997
    Date of Event
    May 26, 1997
    Report Date
    June 3, 1997
    Manufacturer
    AMS, PFIEER
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FLUID LOSS FROM PENILE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS Implant PENILE PROSTHESIS FHW AMS, PFIEER * 3426-P006,0165P008,7191M009

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization