BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 89563 · Received May 7, 1997

    Report

    Report Number
    2126328-1997-02179
    Event Type
    Injury
    Date Received
    May 7, 1997
    Date of Event
    October 25, 1996
    Report Date
    May 7, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. T ON 11/22/83 WITH EXPLANT ON
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED ON 6/10/97 INDICATES THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT ON 10/25/96 DUE TO "NON-FUNCTIONING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. T ON 11/22/83 WITH EXPLANT ON 700 BW785 008, BW785 008,BW785 008

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R