BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 62654 · Received January 10, 1997

    Report

    Report Number
    2126328-1996-06393
    Event Type
    Injury
    Date Received
    January 10, 1997
    Date of Event
    December 6, 1996
    Manufacturer
    AMERICAN MEDICA SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICA SYSTEMS, INC. 700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R