BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPP INFLATABLE PENILE PROSTHESIS

    MDR report key: 88017 · Received May 2, 1997

    Report

    Report Number
    2125050-1997-00226
    Event Type
    Injury
    Date Received
    May 2, 1997
    Date of Event
    January 28, 1997
    Report Date
    May 2, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION." ADD'L SERIAL #012118.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPP INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA 012004/025615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention