BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 10832372 · Received November 12, 2020

    Report

    Report Number
    3011423170-2020-00116
    Event Type
    Injury
    Date Received
    November 12, 2020
    Report Date
    October 14, 2020
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K173759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION REGARDING THE TREATMENT TIP, INCLUDING LOT NUMBER WAS REQUESTED, BUT NOT RECEIVED. ADDITIONAL MEDICAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED. ACCORDING TO THERMAGE CPT SYSTEM TECHNICAL USER¿S MANUAL BURNS AND BLISTERS 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. THE EVENT WAS NOT CONFIRMED SINCE NO TREATMENT TIP OR DATA CARD LOG WERE RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSIONS CAN BE DRAWN.

    Additional Manufacturer Narrative · 0

    CORRECTED G4: PMA/510(K) FROM K132431 TO K173759. DATA LOGS WERE UNABLE TO BE REVIEWED. THE SYSTEM HAS SOFTWARE SAFEGUARDS (SUCH AS A POWER ON SELF-TEST) THAT WILL TRIGGER ERROR/EVENT CODES SHOULD SYSTEM BE OUTSIDE OF ACCEPTABLE LIMITS. THE PRODUCT WAS RETURNED AND EVALUATED. THE TIP PASSED THE FLOW, LEAK, AND THERMISTOR TESTS. THE TIP PASSED VISUAL INSPECTION AS NO DIELECTRIC BREAKDOWN WAS OBSERVED. FUNCTIONAL TESTING WAS PERFORMED ((B)(4) TREATMENTS) WITH NO ERRORS OR OTHER ISSUES OBSERVED. SERVICE WAS UNABLE TO CONFIRM THE CAUSE OF THE COMPLAINT. ACCORDING TO THERMAGE CPT SYSTEM TECHNICAL USER¿S MANUAL, BURNS AND BLISTERS ARE KNOWN POSSIBLE PATIENT REACTION TO 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 TO REMOVAL WITH A LASER DEVICE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE DRAWN. NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED BUT NOT YET RECEIVED. A REVIEW OF THE MANUFACTURING RECORDS IS IN PROGRESS. BASED ON ALL AVAILABLE INFORMATION NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A DOCTOR¿S OFFICE REPORTED THAT MULTIPLE PATIENTS HAVE EXPERIENCED BLISTERS AFTER UNDERGOING A THERMAGE TREATMENT. NO DETAILS OF THE INCIDENT/S HAVE BEEN PROVIDED AND NO PATIENT DETAILS HAVE BEEN PROVIDED AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297271 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS3.00E4-1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown