BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 93777 · Received May 22, 1997

    Report

    Report Number
    2126328-1997-02238
    Event Type
    Injury
    Date Received
    May 22, 1997
    Date of Event
    April 1, 1997
    Report Date
    May 22, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE IPP DEVICE WAS REMOVED FROM THE PATIENT DUE TO FLUID LOSS. REF. ACCESS #1011289.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 1940L 026 1940L 026 (MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Hospitalization| R