BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTREX

    MDR report key: 115756 · Received August 27, 1997

    Report

    Report Number
    MW1011959
    Event Type
    Injury
    Date Received
    August 27, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AT THE TIME OF THIS REPORT AUG 27, 1997 RPTR HAD TO GO FOR ANOTHER PENILE IMPLANT ON JUNE 30, 1998. THE AMS PENILE PROSTHESIS RUPTURED AND COLLAPSED ONLY AFTER NINE MOS. MY NEW PROSTHETICS IS FROM MENTOR. THIS HAS BEEN THE EIGHT TIME RPTR HAD PENILE SURGERY SINCE 1985. RPTR WRITES, " I DO HOPE THE INFO I AM PROVIDNG WILL BE OF SOME BENEFIT.

    Description of Event or Problem · 1

    RPTR WRITES "I HAD A PENILE IMPLANT ON AUG 12, 97 AND THIS PENILE PROSTHESIS BROKE DOWN ON MAY 17, 98 IN LESS THAN A YR. I HAVE HAD A HORRIBLE ORDEAL WITH PENILE IMPLANTS, I HAVE ALREADY HAD SEVEN OPERATIONS SINCE 1985. NOW I AM FACING YET ANOTHER IMPLANT OPERATION. THE DEVICES THAT HAVE BEEN USED WERE THE ULTREX FROM AMRICAN MED SYSTEMS INC PFIZER HOSP PRODUCTS GROUP; 10700 BREN RD W, MINNETONKA, MN 55343. (1800) 328-3881." " I AM NOW DEVASTATED MENTALLY, FULL OF ANXIETY. MY LIFE IS A "EXPLOTIVE DELETED" OVER THE LATEST PENILE IMPLANT FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTREX Implant INFLATABLE PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR