BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY

    MDR report key: 4232938 · Received November 6, 2014

    Report

    Report Number
    2183959-2014-00494
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 2, 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

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT SOME PATIENTS NEEDED A CATHETER TO BE INSERTED AFTER TREATMENT DUE TO URINARY RETENTION. THERE WERE NO PATIENTS THAT NEEDED A COLPOSCOPY BAG AFTER TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSOLE TEMPERATURE WENT BEYOND THE PRESCRIBED TEMPERATURE AND CAUSED DISCOMFORT TO THE PATIENT. ALSO, DUE TO THE HIGHER TEMPERATURE, IT WAS INDICATED THAT THE PATIENT NEEDED A COLPOSCOPY BAG LONGER AND A CATHETER NEEDED TO BE INSERTED AFTER TREATMENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712916 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