BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MJOULE

    MDR report key: 23361457 · Received October 22, 2025

    Report

    Report Number
    2953696-2025-00049
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    August 9, 2025
    Report Date
    October 22, 2025
    Manufacturer
    SCITON INC.
    Product Code
    GEX
    UDI-DI
    00863249000329
    PMA / PMN Number
    K101916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025: SCITON CLINICAL SPECIALIST REACHED OUT TO CLINIC LASER SAFETY OFFICER. PICTURES WERE SENT ALONG WITH THE FOLLOWING SETTINGS. DATE OF TREATMENT: (B)(6) 2025. 560 FILTER, 15 X 15, 8 J, 15 PW, 15°C, 2 PASSES. 560 FILTER, 7MM, 20 J, 10PW, 20°C, 1 PASS. 515 FILTER, 7MM, 15-17 J, 15 PW, 20°C, 1 PASS. SCITON CLINICAL SPECIALIST NOTED DIFFUSE ERYTHEMA AND SWELLING IN PICTURE. ASKED CLINIC LSO FOR UPDATED PHOTOS AND CLINICAL DOCUMENTATION. ON (B)(6) 2025: CLINIC LSO EMAILED TO SCITON CLINICAL SPECIALIST THAT UPDATED PHOTOS ARE NOT AVAILABLE AND CLINIC NP WOULD HAVE TO PROVIDE CLINICAL DOCUMENTATION. ON (B)(6) 2025: CLINIC NP PROVIDED THE FOLLOWING DOCUMENTATION TO SCITION CLINICAL SPECIALIST: "THE PATIENT WAS PRESCRIBED MUPIROCIN 2% OINTMENT BID ON (B)(6). I ATTEMPTED REACHING OUT TO THE PATIENT WITH NO RESPONSE X3. DOCUMENTATION AS FOLLOWS: NOTES: ON (B)(6) 1430: NOTIFIED OF CLINICAL ISSUE PER SERVICE PROVIDER. REVIEWED PHOTOS SENT PER PROVIDER, POST PROCEDURE PHOTOS REVEAL MODERATE ERYTHEMA WITH SCATTERED BLANCHED AREAS THROUGHOUT BILATERAL CHEEKS. APPROXIMATELY ONE HOUR POST TREATMENT, PHOTO RECEIVED FROM PATIENT REVEALING NICKEL SIZED BULLA NOTED TO THE RIGHT-SIDE MIDWAY BETWEEN TRAGUS OF EAR AND ORAL COMMISSURE. NO OTHER PHOTOS WERE RECEIVED AT THIS TIME. DISCUSSED TREATMENT SETTINGS WITH PROVIDER, PRE TREATMENT QUESTIONS WITH NO RECENT USE OF ANTIBIOTICS, RETINOLS/ACIDS. PROVIDER REPORTS AFTER PERFORMING SERVICE, SHE SAW THE PT WAS CLEARED FOR SERVICES RATHER THAN CONDITIONALLY CLEARED AND PT REPORTED TO DOCOVIA SHE WAS ON A RETINOL RECENTLY. CALLED PT TO DISCUSS POC. PATIENT REPORTS SHE USES PRESCRIPTION AZELAIC ACID AND THE LAST USE WAS A FEW DAYS PRIOR TO TX, NO OTHER PRESCRIPTION MEDICATION OTHER THAN SPIRONOLACTONE. PATIENT REPORTS SHE HAD A 'LARGE BLISTER ON THE RIGHT CHEEK THE SIZE OF A NICKEL, BUT IT BURST WHILE SLEEPING' AND NOW SHE HAS 'MULTIPLE SMALL BLISTERS ON THE LEFT SIDE UNDER THE CHEEK BONE'. PATIENT REPORTS MILD SWELLING UNDER HER EYES. REPORTS NO DRAINAGE AT THIS TIME. EDUCATED ON IMPORTANCE OF KEEPING AREA CLEAN AND DRY, IMPORTANCE OF AVOIDING TOUCHING THE AREA/ALLOWING ITEMS TOUCHING THE AREA, AVOIDING HARSH TOPICALS/SOAPS OVER THE AREA, AND IMPORTANCE OF FREQUENT HAND WASHING PRIOR TO CARING FOR THE AREA, V/U. EDUCATED TO AVOID 'POPPING' THE BLISTERS TO ALLOW THEM TO HEAL ON THEIR OWN, AND TO AVOID THE SUN/OVERHEATING UNTIL THE AREA IS HEALED, V/U. PATIENT TO SEND PHOTOS TO CLINIC EMAIL FOR REVIEW, V/U. REPORTS NKA, REVIEWED MUPIROCIN OINTMENT, HOW TO USE/BENEFITS, V/U. MUPIROCIN 2% OINTMENT BID SENT TO PT PREFERRED PHARMACY. EDUCATED PATIENT ON IMPORTANCE OF AVOIDING ANY TOPICAL ACIDS/RETINOLS FOR ONE WEEK PRIOR TO NEXT TX AND THAT WE MAY PERFORM A TEST SPOT BEFORE TREATING FULL FACE AT NEXT TX, V/U. TO FOLLOW UP AGAIN FREQUENTLY THIS WEEK. NOTE BY CLINIC NP ON (B)(6) 2025 1:19 PM-CALLED PT TO CHECK IN. VM LEFT. NOTE BY CLINIC NP ON (B)(6) 2025 11:23 AM-CALLED PT. VM LEFT. NOTE BY CLINIC NP ON (B)(6) 2025 2:56 PM-NO RESPONSE FROM PT. CLOSING ISSUE." ON (B)(6) 2025: SCITON CLINICAL SPECIALIST FOLLOWED UP WITH CLINIC LSO AND NP AND REVIEWED THE FOLLOWING WITH STAFF: BBL PROTOCOL, CORRECTIVE PROTOCOL AND CLINICAL ENDPOINTS. 10/15/25: SCITON SERVICE ENGINEER CHECKED THE DEVICE IN CLINIC ON 1015/2025, AND THE SYSTEM PASSED ALL SAFETY AND OPERATIONAL TESTS AND IS READY FOR USE. ON (B)(6) 2025: ACCORDING TO SCITON CLINICAL SPECIALIST, HER CLINICAL ASSESSMENT ON THIS CASE WOULD BE CONSIDERED ASSUMPTIONS NOT FACTS AS SHE DOES NOT THINK SHE WAS PROVIDED ENOUGH PRE/POST TREATMENT PHOTOS OR CLINICAL DOCUMENTATION TO EFFECTIVELY GIVE A PROPER CLINICAL ANALYSIS. THE ONLY PICTURE PROVIDED WAS POST TREATMENT ERYTHEMA, WHICH CAN BE A NORMAL RESPONSE FOR HIGHLY VASCULAR PATIENTS. NO PHOTOS OF THE BLISTERS REPORTED BY PATIENT WERE SENT. THE SETTINGS IN THIS CASE NEEDED CLARIFICATION, IT WAS THE 560NM FILTER USED FOR BASE PASSES OR FOR CORRECTIVE. IF IT WAS FOR CORRECTIVE, THEN IT COULD BE A CASE OF OVERTREATMENT, BUT THAT FACT COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    TREATMENT DATE: (B)(6) 2025 SCITON CLINICAL SPECIALIST RECEIVED EMAIL FROM THE CLINIC LASER SAFETY OFFICER WITH PICTURES. SCITON CLINICAL SPECIALIST CANNOT DETERMINE DEGREE OF BURN DUE TO LACK OF INFORMATION PROVIDED, AND NO UPDATED PICTURES AVAILABLE. PICTURES SENT SHOWED ERYTHEMA AND A SLIGHT DEGREE OF SWELLING. THE CLINIC USER ALSO REPORTED TO SCITON SERVICE THAT THEY ARE EXPERIENCING MUCH MORE BRUISING THAN NORMAL DURING VASCULAR WITH THE 560 FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402066 MJOULE POWERED LASER SURGICAL INSTRUMENT GEX SCITON INC. MJOULE 52220 00863249000329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention