BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 99612 · Received June 19, 1997

    Report

    Report Number
    99612
    Event Type
    Injury
    Date Received
    June 19, 1997
    Date of Event
    June 5, 1997
    Report Date
    June 18, 1997
    Manufacturer
    AMS, PFIZER
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFECTED PENILE PROSTHESIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS Implant PENILE PROSTHESIS FHW AMS, PFIZER * BP874007, BN488010, BX431006

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization