BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHA I MENTOR 3 PART INFLATABLE PENILE PROSTHESIS

    MDR report key: 524098 · Received April 27, 2004

    Report

    Report Number
    524098
    Event Type
    Malfunction
    Date Received
    April 27, 2004
    Date of Event
    February 1, 2004
    Report Date
    March 1, 2004
    Manufacturer
    MENTOR MINNESOTA, INC.
    Product Code
    FWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT UNDERWENT EXPLANTATION OF A NON-FUNCTIONING MENTOR 3 PART INFLATABLE PENILE PROSTHESIS AND IMPLANTATION OF AN ALPHA 1 MENTOR 3 PART PROSTHESIS. THE PT NOTED THAT THE IMPLANT WORKED WELL UNTIL PATIENT HAD SOME TRAUMA TO THEIR GROIN AREA AND PUMP NO LONGER FUNCTIONED. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I MENTOR 3 PART INFLATABLE PENILE PROSTHESIS PENILE PROSTHESIS FWH MENTOR MINNESOTA, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other