BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTREX PLUS PENILE PROSTHESIS

    MDR report key: 562234 · Received December 15, 2004

    Report

    Report Number
    562234
    Event Type
    Other
    Date Received
    December 15, 2004
    Date of Event
    October 26, 2004
    Report Date
    December 15, 2004
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A RUPTURE OF THE OUTER SILICONE SHEATH, WITH EXPOSURE OF DACRON ALONG MOST OF THE ENTIRE LENGTH OF THE CYLINDER. THE CYLINDER WAS REMOVED, AND ALL COMPONENTS APPEARED TO BE PRESENT, ALTHOUGH IN PIECES.THIS LEFT CYLINDER, HOWEVER, WAS REMOVED WITH DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTREX PLUS PENILE PROSTHESIS ULTREX PLUS RESERVOIR FHW AMERICAN MEDICAL SYSTEMS, INC. 72401477 NOT REPORTED
    2 ULTREX PLUS ULTREX CYLINDERS FHW AMERICAN MEDICAL SYSTEMS, INC. 72401467 NOT REPORTED
    3 ULTREX PLUS ULTREX PREPERATION PACKAGE FHW AMERICAN MEDICAL SYSTEMS, INC. 72400001 NOT REPORTED
    4 ULTREX PLUS ULTREX QUICK CONNECTOR FHW AMERICAN MEDICAL SYSTEMS, INC. 72401633 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR