BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS INC

    MDR report key: 467500 · Received June 18, 2003

    Report

    Report Number
    467500
    Event Type
    Injury
    Date Received
    June 18, 2003
    Date of Event
    June 3, 2003
    Report Date
    June 17, 2003
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC, PFIZER HOSPITAL PRODUCTS GROUP
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSPITAL FOR REVISION OF PENILE IMPLANT SECONDARY TO MALFUNCTION. PT NOTICED AN ANEURSYMAL TYPE DEFECT ON RIGHT SHAFT NEAR BASE OF PENIS. DEVICE APPEARED TO INFLATE ADEQUATELY BUT THERE WAS SIGNIFICANT ENLARGEMENT AT THE BASE OF THE PENIS ON PHYSICAL EXAM. THE PENIS DEVIATED TOWARD THE LEFT DUE TO THIS DEFECT. ORIGINAL PENILE IMPLANT WAS PLACED 5 YEARS AGO. IT WAS AN AMS ULTREX 3 PIECE INFLATABLE PENILE PROSTHESIS, 18CM LENGTH WITH 3CM REAR TIP EXTENDERS, AND 100CC BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS INC PENILE PROSTHESIS-ULTREX FHW AMERICAN MEDICAL SYSTEMS, INC, PFIZER HOSPITAL PRODUCTS GROUP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention