BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1941547 · Received December 17, 2010

    Report

    Report Number
    1941547
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 17, 2010
    Manufacturer
    AMS
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE AMS 700 CX PENILE PROSTHESIS HAD A LEAK IN THE TUBING BETWEEN THE RIGHT CYLINDER AND THE RESERVOIR. IT WAS REMOVED AND REPLACED BY THE PHYSICIAN. THE DEVICE WAS RETAINED AT THE DECONTAMINATION AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PENILE PROSTHESIS FHW AMS AMS 700 CX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR