BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 88388 · Received May 1, 1997

    Report

    Report Number
    2126328-1997-01848
    Event Type
    Injury
    Date Received
    May 1, 1997
    Date of Event
    March 27, 1997
    Report Date
    May 1, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED DUE TO FLUID LOSS--RESERVOIR. ADDT'L LOT/SERIAL NO: BP810 006

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 AD389 005,AD389 005,AD389 005

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R