BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACOOL

    MDR report key: 656931 · Received December 22, 2005

    Report

    Report Number
    2954746-2005-00074
    Event Type
    Malfunction
    Date Received
    December 22, 2005
    Date of Event
    August 26, 2005
    Report Date
    December 22, 2005
    Manufacturer
    THERMAGE
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS TREATED ON 08/26/05. DURING TREATMENT THE TREATMENT TIP MADE A LOUD SOUND. DR. INSPECTED THE TREATMENT TIP AND NOTICED A BURN MARK ON THE MEMBRANE. PT DEVELOPED A BURN IN THE UPPER LIP ABOUT 1 SQ CM IN SIZE AND 2-4MM DEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACOOL ELECTROSURGICAL UNIT AND ACCESSORIES GEI THERMAGE TG-1A-115 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other