BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACOOL

    MDR report key: 548850 · Received October 13, 2004

    Report

    Report Number
    2954746-2004-00042
    Event Type
    Injury
    Date Received
    October 13, 2004
    Date of Event
    March 18, 2004
    Report Date
    October 13, 2004
    Manufacturer
    THERMAGE
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS TREATED IN 12/2003. THERMAGE WAS NOTIFIED OF EVENT 3 MOS LATER. PT DEVELOPED INDENTATIONS, GRID PATTERN ON LEFT CHEEK AREA, AT FOUR WEEKS POST TREATMENT. PT HAD BEEN INSTRUCTED TO DO MASSAGE ON THE AREA SEVERAL TIMES A DAY. FOLLOW-UP IN 04/2004; THE INDENTATIONS HAVE IMPROVED ABOUT 60% AND INSTRUCTED TO CONTINUE WITH THE MASSAGES. MOST CURRENT FOLLOW-UP IN 08/2004; THE INDENTATIONS CONTINUE TO STEADILY IMPROVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other