BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR + BRILLIANT LASER SYSTEM

    MDR report key: 13550308 · Received February 17, 2022

    Report

    Report Number
    3011423170-2022-00015
    Event Type
    Injury
    Date Received
    February 17, 2022
    Date of Event
    September 16, 2021
    Report Date
    January 24, 2022
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    ONG
    PMA / PMN Number
    K120433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURN OF THE PRODUCT IS NOT REQUIRED FOR THIS CASE. THE CLEAR + BRILLIANT TREATMENT TIPS DO NOT DELIVERY ANY ENERGY AND NO TREATMENT DATA IS STORED ON THE TIP ITSELF; THERE IS NO INFORMATION TO GATHER FROM THEIR RETURN. FOR OTHER REPORTED EVENTS, TIPS ARE NOT A VIABLE SOURCE OF EVALUATION DATA. THE SYSTEM HAS NO SYSTEM/DATA LOGS THAT CAN BE REVIEWED. THE SYSTEM HAS SOFTWARE SAFEGUARDS THAT WILL TRIGGER ERROR/EVENT CODES SHOULD THE SYSTEM BE OUTSIDE OF ACCEPTABLE LIMITS.

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CLINIC. NO PRODUCT WAS RETURNED FOR EVALUATION. THE CUSTOMER CAN ALSO UTILIZE THE BURN PAPER TO CONFIRM SYSTEM LASER IS PROVIDING CORRECT PATTERN/COVERAGE. THE CUSTOMER DID NOT PERFORM THE REQUESTED PATTERN PAPER TEST; THUS, WE CANNOT VERIFY THE PROPER PATTERN/COVERAGE. IT IS THE RESPONSIBILITY OF THE CUSTOMER TO PERFORM THE PATTERN PAPER TEST AND SUBMIT FOR REVIEW AND IF THEY DO NOT, THERE ARE NO FURTHER ACTIONS TO BE TAKEN. ACCORDING TO CLEAR+BRILLIANT USER MANUAL AND SYSTEM HAZARD ANALYSIS, BURNS AND INFECTION ARE KNOWN POSSIBLE COMPLICATIONS OF THE TREATMENT. A RISK OF INFECTION EXISTS WHENEVER THE SKIN IS WOUNDED. THE POSSIBILITY FOR INFECTION EXISTS EVEN WITH NON-ABLATIVE FRACTIONAL LASER DEVICES SUCH AS CLEAR + BRILLIANT. IF OBSERVED, INFECTION SHOULD BE TREATED APPROPRIATELY WITH TOPICAL AND/OR SYSTEMIC MEDICATIONS. DUE TO THE LACK OF INFORMATION PROVIDED, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE DRAWN. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A PATIENT REPORTED POST-OPERATIVE BLISTERS AND PUSTULES OCCURRING 2 DAYS FROM A TREATMENT WITH CLEAR AND BRILLIANT TIPS THAT WAS PERFORMED ON (B)(6) 2021. ONE DAY AFTER THE PATIENT REPORTED THIS TO SOLTA MEDICAL, INC, THE PATIENT CALLED BACK TO REPORT THAT SHE HAS A SPREADING INFECTION TO HER NOSE AND IS STILL IN PAIN AFTER SEVERAL MONTHS. SHE REPORTED THAT SHE WAS NERVOUS THAT SHE CAUGHT AN INFECTIOUS DISEASE SINCE SHE WAS BURNED/CUT AND BLEEDING DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943543 CLEAR + BRILLIANT LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM ONG SOLTA MEDICAL, INC 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown