BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE CPT SYSTEM AND ACCESSORIES

    MDR report key: 17549200 · Received August 15, 2023

    Report

    Report Number
    3011423170-2023-00074
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    July 19, 2023
    Report Date
    July 19, 2023
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K173759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THOUGH REQUESTED, THE TREATMENT TIP HAS NOT BEEN PROVIDED FOR EVALUATION. A MEDICAL REVIEW OF THIS CASE DETERMINED THAT THIS EVENT WAS NOT A SERIOUS INJURY. AS SUCH, THIS EVENT NO LONGER MEETS MDR REPORTABILITY REQUIREMENTS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. NO NON-CONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. THE LOT/DEVICE HISTORY REVIEW AND TREND ANALYSIS ARE CONSIDERED ACCEPTABLE, AND THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. ACCORDING TO THERMAGE CPT SYSTEM TECHNICAL USER¿S MANUAL, BURNS ARE KNOWN POSSIBLE PATIENT REACTION TO THERMAGE TREATMENT. THE PROCEDURE MAY PRODUCE HEATING IN THE UPPER LAYERS OF THE SKIN, CAUSING BURNS AND SUBSEQUENT BLISTER AND SCAB FORMATION. THERE IS A SMALL CHANCE OF SCAR FORMATION. APPLICATION OF TOPICAL STEROIDAL OR ANTIBIOTIC PREPARATIONS MAY BE OF BENEFIT. IN THE RARE INSTANCE OF A BURN THAT RESULTS IN A SCAR, THE SCAR WILL PROBABLY BE VERY SMALL AND RESPOND READILY TO REMOVAL WITH A LASER DEVICE. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE DRAWN. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE TREATMENT TIP HAS BEEN REQUESTED FOR EVALUATION. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE REPORTER. THERE WAS NO SECONDARY INTERVENTION PROVIDED TO THE PATIENT AS A RESULT OF THIS EVENT. THE PATIENT IS NOW FINE, WITH NO PERMANENT DAMAGE OR SCARRING. THE SOLTA MEDICAL REVIEWER HAS REASSESSED THIS FILE AND IT IS NOW CONSIDERED A NOT SERIOUS EVENT. THIS EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS AS THE ADVERSE EVENT WAS NOT SERIOUS.

    Description of Event or Problem · 0

    A PATIENT IN INDIA REPORTED AN ADVERSE EVENT WHERE THEY EXHIBITED BURNS TO THE LEFT CHIN AFTER A THERMAGE CPT FACIAL TREATMENT. NO OTHER TREATMENTS WERE BEING PERFORMED IN THE AREA WHERE THE TREATMENT WAS REPORTED. THE POWER SETTING USED WAS 1.5 AND 2 KJ AND THE INCIDENT OCCURRED ON THE 70TH SHOT. THE SURGEON THEN STOPPED THE TREATMENT. NO SYSTEM ERRORS OCCURRED AND NOTHING OUT OF THE ORDINARY WAS OBSERVED DURING THE TREATMENT. SOLTA MEDICAL CRYOGEN AND 30ML SOLTA MEDICAL COUPLING FLUID WERE USED. THE TREATMENT TIP HAD NOT BEEN USED BEFORE AND WAS INSPECTED PRIOR TO USE AND EVERY TEN SHOTS, WITH NO ANOMALIES NOTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246743 THERMAGE CPT SYSTEM AND ACCESSORIES ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI GEI SOLTA MEDICAL, INC. TTNS3.00C1-400

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown