BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 44990 · Received October 24, 1996

    Report

    Report Number
    2126328-1996-04790
    Event Type
    Injury
    Date Received
    October 24, 1996
    Date of Event
    August 26, 1996
    Report Date
    October 24, 1996
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 10/17/91 DEVICE WAS IMPLANTED. ON 4/12/96 THE RESERVOIR WAS REVISED. ON 8/26/96 THE DEVICE WAS REMOVED FROM THE PT DUE TO INFECTION. ADD'L LOT/SER NO: BK134 005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant IPP FHW AMERICAN MEDICAL SYSTEMS, INC. 700 9963L 014,9963L 014,5000M 009

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R