BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY

    MDR report key: 4241432 · Received November 10, 2014

    Report

    Report Number
    2183959-2014-00501
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    September 8, 2014
    Report Date
    October 14, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    MEQ
    PMA / PMN Number
    P000043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSOLE IN QUESTION WAS RETURNED FOR EVALUATION. ANALYSIS RESULTS INDICATE THE CONSOLE PERFORMED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSOLE TEMPERATURE WENT BEYOND THE PRESCRIBED TEMPERATURE AND CAUSED DISCOMFORT TO THE PATIENT. IT WAS ALSO INDICATED THAT SOME PATIENT'S NEEDED A CATHETER TO BE INSERTED AFTER TREATMENT DUE TO URINARY RETENTION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721805 AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BPH), THERMOTHERAPY MEQ AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention