BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 93853 · Received May 30, 1997

    Report

    Report Number
    2125050-1997-00298
    Event Type
    Injury
    Date Received
    May 30, 1997
    Date of Event
    July 4, 1994
    Report Date
    May 30, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN INVESTIGATION INTO A SUBSEQUENT EVENT, A PREVIOUSLY UNREPORTED EVENT WAS DISCOVERED. PER THE INFO PROVIDED TO CO BY THE PTS REP THROUGH MEANS OF CO'S INTL REP, IT STATED,..."AFTER A REVISION OF THE PROSTHESIS IN OCTOBER OF '93, THE PT SUFFERED PAIN FOR A LONG PERIOD OF TIME, WHICH BROUGHT HIM BACK TO THE HOSPITAL ON NOVEMBER 16-20, 1993. ANOTHER HOSPITALIZATION WAS NECESSARY ON FEBRUARY 8-12, 1994 DUE TO CONTRACTIONS AND PAIN, WHEN THE PT ASSUMED A SITTING POSITION. FINALLY THE PT WAS HOSPITALIZED ON MARCH 20 THRU MAY 9, 1994 DUE TO PRESSURE NECROSIS ON THE SCROTUM. THE PT WAS HOSPITALIZED AGAIN FROM JUNE 16 THRU JULY 26, 1994 AS THE PENILE CYLINDER(S) CAME OUT THROUGH THE GLANS OF THE PENIS. THE PROSTHESIS WAS REMOVED ON JULY 4, 1994".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90030/E90032/E90059

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention