BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 700 SPHERICAL RESERVOIR WITH INHIBIZONE

    MDR report key: 7137670 · Received December 21, 2017

    Report

    Report Number
    7137670
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 21, 2017
    Report Date
    December 12, 2017
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    JCW
    UDI-DI
    00878953003207
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PENILE PROSTHESIS WAS REMOVED DUE TO A CYLINDER RUPTURE 3 YEARS POST IMPLANTATION. REPLACEMENT PROCEDURE WAS PERFORMED WITHOUT COMPLICATION AND PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916832 AMS 700 SPHERICAL RESERVOIR WITH INHIBIZONE PROSTHESIS, PENIS, INFLATABLE JCW AMERICAN MEDICAL SYSTEMS, INC. 72404155 880258007 00878953003207

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR