BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 11630827 · Received April 7, 2021

    Report

    Report Number
    3011423170-2021-00040
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 5, 2021
    Report Date
    March 12, 2021
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ERROR INDICATES A RECOVERABLE PROBLEM THAT REQUIRES OPERATOR INTERVENTION. IF THE ERROR OCCURS DURING AN RADIO FREQUENCY TREATMENT, THE RADIO FREQUENCY DELIVERY WILL BE STOPPED, THEN A POST-COOLING STEP WILL BE COMPLETED PRIOR TO GENERATING AN ¿ERROR TONE¿ AND DISPLAYING THE EVENT CODE AND EVENT MESSAGE. AFTER THE ERROR TONE, THE SYSTEM WILL TRANSITION INTO ¿ACTION REQUIRED¿ MODE AND WILL DISPLAY TEXT WITH INSTRUCTIONS FOR THE OPERATOR INDICATING WHAT ACTION MAY BE REQUIRED TO RESOLVE THE ISSUE. BURNS ARE KNOWN POSSIBLE ADVERSE PATIENT REACTIONS TO A THERMAGE TREATMENT. THERMAGE SYSTEM TECHNICAL USER MANUAL (P009240-04 REV. A) STATES 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. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. THE TREATMENT TIP AND DATA-CARD LOG WERE RETURNED FOR EVALUATION. BASED ON THE EVALUATION OF THE DATA, THE HANDPIECE, SYSTEM, AND TIP PERFORMED AS EXPECTED. EVALUATION OF THE TREATMENT TIP DID NOT FIND ANY ISSUES RELATED TO THE TIP. THE TIP PASSED SECONDARY LEAK, THERMISTOR, AND VISUAL TESTING. BASED ON THE AVAILABLE INFORMATION WE CONCLUDE BURNS ARE A KNOWN POSSIBLE REACTION TO TREATMENT.

    Additional Manufacturer Narrative · 1

    THE TREATMENT TIP AND TREATMENT DATA LOG HAVE BEEN RETURNED FOR EVALUATION. TIP EVALUATION IS NOT YET COMPLETED. EVALUATION OF THE DATA LOG INDICATES THE SYSTEM AND HANDPIECE PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORD IS ONGOING. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PHYSICIANS OFFICE CALLED TO REPORT THAT THEIR PATIENT EXPERIENCED A FACIAL BURN BY THE LEFT EYE FOLLOWING A THERMAGE TREATMENT. THE REPORTER INDICATED THAT THE PATIENT UNDERWENT A THERMAGE EYE TREATMENT WITH A MAXIMUM POWER LEVEL OF 2.5. AMPLE COUPLING FLUID WAS USED THROUGHOUT THE TREATMENT AND THE TREATMENT TIP WAS INSPECTED PRIOR TO AND DURING TREATMENT WITH NO OBSERVED ABNORMALITIES. THE REPORTER DID INDICATE THAT THERE WAS AN UNUSUAL NOISE OBSERVED COMING FROM THE HANDPIECE DURING TREATMENT. FOLLOWING TREATMENT THE PATIENT DEVELOPED A BURN NEAR THE LEFT EYE. THE NATURE OF THE INJURY WAS CONFIRMED AS VESICLES AND ERYTHEMA. THE PATIENT WAS TREATED BY FUCICORT CREAM. PATIENT PHOTOS WERE REVIEWED, A LIGHT HYPERPIGMENTED LESION IS VISIBLE LATERAL TO THE LEFT EYE AS WELL AS A CRUSTED LESION IS VISIBLE LATERAL TO THE LEFT EYE THAT LATER RECOVERED WITH A SMALL RING-SHAPE SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525461 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL INC. TTNS0.25NB1-450 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention