BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES

    MDR report key: 14372102 · Received May 12, 2022

    Report

    Report Number
    3011423170-2022-00050
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    February 3, 2022
    Report Date
    April 12, 2022
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TREATMENT TIP AND SYSTEM DATA LOGS WERE RETURNED AND EVALUATED. EVALUATION OF THE TREATMENT DATA INDICATES THAT THE SYSTEM AND HAND PIECE PERFORMED AS EXPECTED DURING TREATMENT. THE TIP PASSED THERMISTOR TESTING. THE TIP FAILED THE LEAK TEST. THE TIP FAILED VISUAL INSPECTION DUE TO THE OBSERVANCE OF DIELECTRIC BREAKDOWN BEGINNING TO FORM ON THE RADIO FREQUENCY TRACE. NO DENTS OR SCRATCHES WERE OBSERVED. NO FUNCTIONAL TESTING WAS POSSIBLE DUE TO THE CONDITION OF THE RETURNED DEVICE. A REVIEW OF THE DEVICE MANUFACTURING RECORD IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    SERVICE RE-EVALUATED THIS CASE AND IT WAS DETERMINED THAT NO DIELECTRIC BREAKDOWN WAS FOUND ON THE TIP. THE INFORMATION PROVIDED DOES NOT SUGGEST THIS INCIDENT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, SERIOUS INJURY OR A SERIOUS DETERIORATION IN STATE OF HEALTH. THIS EVENT IS NO LONGER DEEMED REPORTABLE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEIR PATIENT UNDERWENT A THERMAGE FLX TREATMENT AFTER WHICH IT WAS OBSERVED THERE WERE SMALL RED SPOTS ON THE PATIENTS RIGHT SIDE ABDOMEN. IT WAS ALSO NOTED THAT THE SYSTEM DISPLAYED THE ERROR CODE FOR "TIP TOO WARM" DURING THE ABDOMEN TREATMENT. THE CUSTOMER REPORTED THE SPOTS APPEAR TO CORRESPOND TO WHERE THE CENTER OF THE TIP WAS PLACED ON EACH TREATMENT SITE. A REVIEW OF THE CLINICAL DETAILS AND AVAILABLE PATIENT PHOTOS WAS COMPLETED BY A MEDICAL REVIEWER AND IT WAS DETERMINED NO SERIOUS INJURY WAS EXPERIENCED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132411 THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TT4.00F6-900 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown