BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MJOULE

    MDR report key: 23361458 · Received October 22, 2025

    Report

    Report Number
    2953696-2025-00050
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 22, 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

    (B)(6) 2025: SCITON CLINICAL SPECIALIST RESPONDED TO CLINIC LASER SAFETY OFFICER COMPLAINT REGARDING A PATIENT. TREATMENT DATE (B)(6) 2025. CLINIC LSO HAD SENT PICTURES THAT WERE BLURRY AND NO REACTION WAS SEEN ALONG WITH THE SETTINGS WHICH WERE: 515 FILTER 15X15 14J 12 PW 23C 2 PASSES. 560 FILTER 15 X15 10J 25 PW 23 C 2 PASSES. SCITON CLINICAL SPECIALIST ASKED FOR ANY UPDATED PICTURES AND CLINICAL DOCUMENTATION FROM THIS CASE. (B)(6) 2025: SCITON CLINICAL SPECIALIST ASKED CLINIC LSO TO CALL HER WHEN AVAILABLE. NO RESPONSE. (B)(6) 2025: CLINIC LSO EMAILED SCITON CLINICAL SPECIALIST THAT THERE WERE NO UPDATED PHOTOS AND CLINICAL DOCUMENTATION HAD TO COME FROM CLINIC NP. (B)(6) 2025: CLINIC NP SENT THE FOLLOWING CLINICAL DOCUMENTATION TO SCITON CLINICAL SPECIALIST: NOTES FROM CLINIC NP: (B)(6) 2025: THE PATIENT WAS PRESCRIBED MUPIROCIN 2% OINTMENT BID ON 9/29 AFTER SPEAKING WITH HER. I HAVE UNFORTUNATELY BEEN UNABLE TO REACH HER SINCE OUR VISIT ON (B)(6) AFTER MULTIPLE POINTS OF CONTACT. CLINIC NP NOTES "SPOKE WITH PATIENT. UPON REVIEW OF PHOTOS SENT PER PT TO SERVICE PROVIDER (B)(6) PHOTOS REVEAL SMALL AREAS OF ERYTHEMIC PURPURA SCATTERED DIFFUSELY THROUGHOUT RIGHT SIDE OF FACE STARTING IN 3-4 SPOTS ON LATERAL CHEEK APPROXIMATELY 2-3 CM IN LENGTH AND TWO LARGER SPOTS TO RIGHT LATERAL CHIN THAT ARE APPROXIMATELY 2CMX3CM WITH CENTRAL AREA THAT APPEARS TO BE VESICLES (DIFFICULT TO VISUALIZE IN PHOTO), SMALLER NOTABLE AREAS TO LOWER NECK AND LEFT LATERAL CHIN. DR. IS AWARE OF CLINICAL ISSUE. PHOTOS RECEIVED (B)(6) PER SERVICE PROVIDER REVEAL THE TWO LARGER SPOTS ARE UNCHANGED, OTHER AREAS WITH SLIGHT IMPROVEMENT. PATIENT REPORTS SHE HAS TWO AREAS TO THE RIGHT LATERAL CHIN THAT ARE OPEN THAT INITIALLY WERE BLISTERED BUT FEELS EVERYWHERE IS IMPROVING. PATIENT REPORTS SHE HAS BEEN USING BACITRACIN AND ARNICA TOPICAL CREAM AND HAS BEEN KEEPING AREA CLEAN WITH FREQUENT HAND WASHING. REPORTS NO DRAINAGE, PAIN, ERYTHEMA, OR WARMTH TO THE AREAS. REPORTS SHE HAS BEEN AVOIDING EXCESSIVE HEAT AND SUN EXPOSURE. PATIENT REPORTS PRIOR TO TREATMENT, SHE STOPPED USING TRETINOIN/ACIDS FOR ONE WEEK AND HAS NOT BEEN ON ANY ANTIBIOTICS/STEROIDS FOR TWO WEEKS PRIOR TO TX. REPORTS SHE IS ON TWO ANTIDEPRESSANTS INCLUDING VRAYLAR AND AUVELITY. PATIENT NOTIFIED TO AVOID AUVELITY (IF APPROVED PER PCP) PRIOR TO NEXT TREATMENT AS IT MAY INCREASE PHOTOSENSITIVITY, V/U. REVIEWED POC WITH PT, VU. MUPIROCIN USE/BENEFITS/HOW TO APPLY REVIEWED WITH PT, V/U. REPORTS NKA. MUPIROCIN 2% OINTMENT BID PRESCRIBED TO PHARMACY. PATIENT TO CONTINUE WITH THE ARNICA, AND AVOIDING SUN EXPOSURE/HEAT, USE FREQUENT HAND WASHING, AND KEEPING AREA CLEAN, V/U. FOLLOW UP THIS WEEK. NOTE FROM CLINIC NP ON (B)(6) 2025- LATE POST: HAVE CALLED PATIENT MULTIPLE TIMES THROUGHOUT THE WEEK VIA DOXIMITY AND THE SPA PHONE, TEXTED VIA ZENOTI APP. VM LEFT, NO RESPONSE FROM PATIENT" (B)(6) 2025: SCITON CLINICAL SPECIALIST REVIEWED BBL PROTOCOL ON CORRECTIVE SETTINGS, NUMBER OF PASSES, AND CLINICAL OUTCOMES WITH THE CLINIC STAFF. (B)(6) 2025: SCITON SERVICE ENGINEER CHECKED THE DEVICE IN CLINIC ON (B)(6) 2025, AND THE SYSTEM PASSED ALL SAFETY AND OPERATIONAL TESTS AND IS READY FOR USE. (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. WHILE IT APPEARS TO LOOK LIKE A CASE OF OVER TREATMENT, SHE WAS NOT ABLE TO EVEN GET A PROPER FITZPATRICK ASSESSMENT. THE SETTINGS PROVIDED, UNDER NORMAL CIRCUMSTANSES WITH A PROPER FITZPATRICK ASSESSMENT SHOULD OFFER AN EFFECTIVE SAFE TREATMENT. THERE WERE NO PHOTOS PROVIDED OF REPORTED BLISTERS BY THE PATIENT, NOR DID THE REPORTING CLINIC NP PROVIDE A PROPER WOUND ASSESSMENT IN HER DOCUMENTATION FOR SCITON CLINICAL TO EFFECTIVELY DIAGNOSE THE BURN.

    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 PICTURES AND INFO PROVIDED. 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
    1402067 MJOULE POWERED LASER SURGICAL INSTRUMENT GEX SCITON INC. MJOULE 52220 00863249000329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention