BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL RE:STORE LASER SYSTEM

    MDR report key: 11697683 · Received April 20, 2021

    Report

    Report Number
    3011423170-2021-00044
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 22, 2021
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    ONG
    PMA / PMN Number
    K091420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS SHOWED THAT ALL REQUIREMENTS WERE MET. FIELD SERVICE ATTENDED THE SITE AND CONDUCTED MACHINE SYSTEM AND FUNCTIONAL TEST. SYSTEM PASSED LASER OUTPUT VERIFICATION, STATIONARY AND FUNCTIONAL BURN TESTS. IT WAS CONFIRMED THE SYSTEM WORKED WITHIN SPECIFICATIONS. THIS EVENT WAS MOST LIKELY UNRELATED TO ANY DEVICE MALFUNCTIONS. BASED ON THE AVAILABLE INFORMATION, BLISTERING AND BURNS ARE KNOWN POSSIBLE PATIENT REACTIONS TO FRAXEL TREATMENT. ACCORDING TO FRAXEL LASER SYSTEMS OPERATOR MANUAL, BLISTERING AND BURNS ARE KNOWN POSSIBLE PATIENT REACTIONS TO FRAXEL TREATMENT AND MAY DEVELOP OVER THE TREATED AREAS. THE POSSIBILITY OF TEMPORARY AND PERMANENT SKIN COLOR CHANGE IS KNOWN TO EXIST WITH ANY LASER TREATMENT.

    Additional Manufacturer Narrative · 1

    MACHINE SYSTEM AND FUNCTIONAL TESTS WERE CONDUCTED AND WORKING TO MANUFACTURES SPECIFICATIONS. THE FRAXEL TREATMENT TIPS DO NOT DELIVER ANY ENERGY AND NO TREATMENT DATA IS STORED ON THE TIP ITSELF; THERE IS NO INFORMATION TO GATHER FROM THEIR RETURN. SYSTEM HAS NO SYSTEM/DATA LOGS THAT CAN BE REVIEWED. SYSTEM HAS SOFTWARE SAFEGUARDS (SUCH AS A POWER ON SELF-TEST) THAT WILL TRIGGER ERROR/EVENT CODES SHOULD SYSTEM BE OUTSIDE OF ACCEPTABLE LIMITS. CUSTOMER CAN ALSO UTILIZE THE BURN PAPER TO CONFIRM SYSTEM LASER IS PROVIDING CORRECT PATTERN/COVERAGE, IN THIS INSTANCE THE CUSTOMER DID NOT PERFORM THIS TEST. A REVIEW OF THE DEVICE HISTORY RECORDS IS IN PROGRESS. BASED ON AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A CLINIC REPORTED THAT AFTER A FRAXEL TREATMENT A PATIENT EXPERIENCED BURNS ON THE DECOLLETAGE AREA. ON ROUTINE FOLLOW UP CALLS FROM THE CLINIC TO THE PATIENT ON (B)(6) 2021, THE PATIENT STATED TO HAVING BOILS/WELTS, ITCHING AND DISCOMFORT ON THE DECOLLETAGE AREA. PATIENT WAS GIVEN A VALTREX SCRIPT, FLAMIGEL TO USE AT HOME AND ADVISED TO USE ANTIHISTAMINES AND PAIN RELIEF FOR ITCHING AND COLD COMPRESSES. WITHOUT CONTACTING THE CLINIC, THE PATIENT PRESENTED TO TWO HOSPITALS THAT WEEKEND WITH PARTIAL THICKNESS BURNS. THE HOSPITAL PROVIDED PATIENT WITH XEROFORM AND PARAFFIN DRESSINGS. PATIENT RETURNED TO A HOSPITAL FOR A SECOND TIME WITH DISCOMFORT AND WORRIED ABOUT THE BURNS. PATIENT HAD BEEN USING PIGMENT INHIBITORS AND RETINOL BUT STOPPED USAGE A WEEK PRIOR TO THE TREATMENT. AVAILABLE PICTURES WERE REVIEWED. LARGE AREA OF BURN OVER THE CHEST AND NECK ARE VISIBLE WITH ERYTHEMA, BLISTERS AND CRUSTS. THE NURSE ONLY USED 1927 WAVELENGTH 10MJ, TX LEVEL #4, 8 PASSES ON THE DECOLLETAGE AREA. NO SYSTEM ERRORS AND NOTHING OUT OF THE ORDINARY OCCURRED DURING THE TREATMENT. A BURN PAPER TEST WAS NOT PERFORMED PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590103 FRAXEL RE:STORE LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM ONG SOLTA MEDICAL INC. MCSR1500-D-INTL 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention