BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 5010151 · Received August 18, 2015

    Report

    Report Number
    5010151
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    June 18, 2015
    Report Date
    August 4, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS INC
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF PROSTATE CANCER AND ERECTILE DYSFUNCTION WAS TAKEN TO SURGERY TO REPLACE A NONFUNCTIONING INFLATABLE PENILE PROSTHESIS. SURGEON STATED "IT HAS NEVER REALLY WORKED AND IS NOT WORKING CURRENTLY DESPITE MULTIPLE ATTEMPTS. SURGERY WAS COMPLETED WITH NO COMPLICATIONS AND AN UNREMARKABLE POST-OP COURSE. PATIENT WAS DISCHARGED THE DAY AFTER SURGERY IN GOOD CONDITION. INFLATABLE PENILE PROSTHESIS HAD BEEN IMPLANTED APPROXIMATELY 6 MONTHS AGO BY ANOTHER SURGEON. THE ORIGINAL PROSTHESIS WAS IDENTIFIED AND INCLUDED THESE PARTS: KIT ACCESS PENILE PROSTHESIS 700, RESERVOIR CONCEAL FLAT 100 ML, EXTENDER REAR TIP PENILE SPECTRA 2 CM, PROSTHESIS PENILE PENOSCROTAL 15 CM, EXTENDER REAR TIP CONE 12 X 14 MM X 1 CM, AND EXTENDER REAR TIP CONE 12 X 14 MM X 1.5 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544066 AMS INFLATABLE PENILE PROSTHESIS PROSTHESIS, PENILE FAE AMERICAN MEDICAL SYSTEMS INC 700 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR