BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 683746 · Received February 15, 2006

    Report

    Report Number
    MW1038033
    Event Type
    Other
    Date Received
    February 15, 2006
    Date of Event
    February 1, 2006
    Report Date
    February 8, 2006
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT THE MATRIX PROCEDURE IN 2005. DEVELOPED VENTRAL DEFLECTIONS PENIS ON ERECTION X2. DESCRIBED SYMPTOMS OF, AND SHOWS PHYSICIAN FINDINGS OF VENTRAL PENILE PEYRONIE'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS THERMATRIX MICROWAVE DEVICE MEQ AMERICAN MEDICAL SYSTEMS RX200-45C 2008-01-23-45

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other