BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 6112886 · Received November 18, 2016

    Report

    Report Number
    0001313525-2016-00610
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 20, 2016
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: ADDITIONAL MFR NARRATIVE. CORRECTION: MFR NAME, CITY, AND STATE, (MANUFACTURER SITE ADDRESS). THE PRODUCT WAS NOT RETURNED FOR EVALUATION. ONLY THE TREATMENT DATA CARD WAS RETURNED TO SOLTA MEDICAL. AN EVALUATION OF THE TREATMENT DATA CARD SHOWED THAT AN ERROR MESSAGE OCCURRED DURING TREATMENT TO ALERT THE USER OF NOT FOLLOWING ON-SCREEN INSTRUCTIONS OR THERE IS A PROBLEM WITH RF NOISE. IF THE ERROR OCCURS DURING TREATMENT, THE RF DELIVERY IS STOPPED AND A POST-COOLING STEP IS COMPLETED, FOLLOWED BY AN ERROR TONE AND DISPLAY OF THE EVENT CODE AND EVENT MESSAGE. AFTER THE ERROR TONE, THE SYSTEM WILL DISPLAY TEXT WITH INSTRUCTIONS FOR THE USER INDICATING WHAT ACTION MAY BE REQUIRED TO RESOLVE THE ISSUE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMITIES OR ANOMALIES RELATED TO THE REPORTED EVENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. NO CAUSAL FACTORS WERE IDENTIFIED. FAT LOSS IS A POSSIBLE PATIENT REACTION TO THERMAGE TREATMENT. SURFACE IRREGULARITIES ARE VARIOUSLY DESCRIBED AS (LOCALIZED) ¿SMALL DENTS IN THE SURFACE OF THE SKIN,¿ ¿RIPPLING,¿ ¿RIDGING,¿ ¿WAFFLE PATTERNS¿, OR ¿FAT LOSS¿ (COVERING A LARGER SURFACE AREA). IN MOST CASES SOLTA RECOMMENDS THAT SURFACE IRREGULARITIES BE MONITORED FOR A PERIOD OF SIX MONTHS POST ONSET. TISSUE FILLERS MAY BE CONSIDERED AS A TREATMENT OPTION IF THE CONDITION DOES NOT RESOLVE ON ITS OWN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DURING AN INTERNAL REVIEW, IT WAS IDENTIFIED THAT THE MEDWATCH REPORT FOR THIS EVENT WAS SUBMITTED ELECTRONICALLY TO FDA WITH AN MDR NUMBER THAT WAS GENERATED USING (B)(4) AS THE REGISTRATION NUMBER. THE CORRECT REGISTRATION NUMBER THAT SHOULD HAVE BEEN USED TO GENERATE THE MDR NUMBER IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEARLY 4 WEEKS POST THERMAGE TREATMENT SESSION, THE PATIENT EXPERIENCED FAT REDUCTION. AREA OF BODY TREATED WAS THE LOWER FACE AT RIGHT HAND SIDE OF JAWLINE. NO OTHER TREATMENT WAS BEING PERFORMED IN THE SAME AREA; HOWEVER, THE PATIENT HAD ONGOING DENTAL WORK IN SAME TREATMENT AREA WITHIN PAST 30 DAYS. REPORTEDLY, NO SYSTEM ERRORS OCCURRED AND THE TREATMENT TIP SURFACE WAS INSPECTED PRIOR TO USE AND DURING TREATMENT EVERY 50-100 PULSES. HIGHEST ENERGY LEVEL USED WAS 2.5. NO OTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765898 THERMAGE CPT SYSTEM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI GEI SOLTA MEDICAL, INC. TG-2B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other