BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS IPP

    MDR report key: 535705 · Received July 21, 2004

    Report

    Report Number
    535705
    Event Type
    Injury
    Date Received
    July 21, 2004
    Date of Event
    July 13, 2004
    Report Date
    July 16, 2004
    Manufacturer
    UNK
    Product Code
    FWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FAILED PENILE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS IPP PENILE PROSTHESIS FWH UNK 72401457 331739001

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization