mJouleRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00863249000329), received between Nov 10, 2023 and Jun 3, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Use of Incorrect Control/Treatment Settings

  (B)(6) 26: SCITON CLINICAL RECEIVED AN EMAIL FROM A CUSTOMER ASKING FOR CLINICAL GUIDANCE ON HOW TO PROCEED TREATING A PATIENT WHO IS BEING TREATED WITH BBL AND RECEIVED A BURN (MINOR BLISTER) FROM A PREVIOUS BBL PROCEDURE PERFORMED IN (B)(6) 2025. PATIENT WAS USING SKIN NECTAR BY ELASTIN. THE PATIENT'S SKIN HAS HEALED AND IS NOW EXPERIENCING AREAS OF HYPOPIGMENTATION.

  Patient problems: Blister; Hypopigmentation; Partial thickness (Second Degree) Burn

  MAUDE report 25385622 ↗
• InjuryApr 7, 2026Use of Incorrect Control/Treatment Settings

  SCITON CLINICAL RECEIVED A CALL FROM A PROVIDER REPORTING THAT A PATIENT RECEIVED AN ADVERSE REACTION POST-BBL ON THE FACE FROM TREATMENT ON (B)(6) 2026.

  Patient problems: Blister

  MAUDE report 24811001 ↗
• InjuryNov 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  10/06/2025: SCITON SERVICE SENT AN EMAIL TO SCITON CLINICAL STATING THAT THE CUSTOMER REPORTED THAT THEY HAD BURNT THE PATIENT ON THE CHIN WITH VERY LIGHT BLISTERING, WHERE THERE ARE SMALL WHITE BUMPS. SCITON SERVICE WILL SCHEDULE A PREVENTIVE MAINTENANCE CALL AND WILL CHECK THE BBL OUTPUT. SCITON SERVICE ASKED SCITON CLINICAL TO REACH OUT TO THE CUSTOMER TO FOLLOW UP.

  Patient problems: Blister; Partial thickness (Second Degree) Burn

  MAUDE report 23459713 ↗
• InjuryOct 22, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  THE SCITON ASSOCIATE AREA SALES REPRESENTATIVE RECEIVED PHOTOS AND A REPORT FROM CLINIC RN THAT ONE OF THE PROVIDERS HAD BURNED A PATIENT'S LEGS PERFORMING FOREVER BARE ON THE MJOULE BBL HEROIC AND SENT A MESSAGE TO [email protected] ON 09/23/2025 AT 10:53 AM. THE TREATMENT WAS PERFORMED AROUND 1:15 PM ON (B)(6) 2025. THE TREATMENT RESULTED IN EVIDENCE OF OVERTREATMENT WITH 2 SMALL BLISTERS AND DISCOLORATION IN THE PATTERN OF THE 15X45 MM BBL SAPPHIRE CRYSTAL.

  Patient problems: Blister; Hypopigmentation

  MAUDE report 23361459 ↗
• InjuryOct 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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.

  Patient problems: Blister

  MAUDE report 23361458 ↗
• InjuryOct 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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.

  Patient problems: Blister

  MAUDE report 23361457 ↗
• InjuryOct 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  TREATMENT DATE: ON (B)(6) 2025, CLINIC'S LASER SAFETY OFFICER EMAILED SCITON CLINICAL THE PICTURE AND SETTINGS OF WHAT SHE CONSIDERED TO BE A POTENTIAL BURN CASE. SCITON CLINICAL SPECIALIST CANNOT DETERMINE DEGREE OF BURN AS THERE WERE NO PICTURES SENT OF ANY BLISTER OR BURN AFTER TREATMENT. THE CLINIC USER ALSO REPORTED TO SCITON SERVICE THAT THEY ARE EXPERIENCING MUCH MORE BRUISING THAN NORMAL DURING VASCULAR WITH THE 560 FILTER.

  Patient problems: Blister; Hypopigmentation

  MAUDE report 23361456 ↗
• InjuryAug 14, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  BURN/BLISTERS POSTERIOR LEGS (B)(6) 2025: CLINIC ADMINISTRATOR SENT AN EMAIL TO THE SCITON CLINICAL DEPARTMENT STATING THE FOLLOWING: "WE HAD A SITUATION CONCERNS IF I NEED THE DEVICE LOOKED AT. THIS IS A PATIENT THAT HAD LASER HAIR REMOVAL (B)(6) 2025 THIS IS HER 4TH TREATMENT. THIS PATIENT DID NOT VERBALIZE ANY CONCERNS PAIN WHILE IN TREATMENT. PER THE PATIENT SHE STATED THAT HER PAIN STARTED LAST EVENING THAT SHE FELT LIKE SHE WAS BURNED. OUR CONCERN, EVEN THOUGH THE PATIENT IS NOT STATING THIS THAT SHE WAS OUT IN THE SUN AND NOT TELLING US. THE VERY ODD THING IS THAT SHE DOES NOT HAVE ANY OF THESE BLISTERS/BURNS THE FRONT OF HER LEGS WHICH WERE TREATED AS WELL. I AM CONFUSED WHY IT SHOWS LIKE THIS AS WE USED THE BBL HEROIC S/N (B)(6) AS THE OLD MACHINES COULD SHOW THESE "BRICK" PATTERNS BUT NOT THE HEROIC. PATIENT IS COMING IN NEXT 20 MINS FOR THE FOLLOWING: APPLICATION OF CO2 LIFT MASK (HYPERBARIC CHAMBER TYPE MASK THESE CAN BE USED POST-SURGERY/POST ABLATIVE LASER ETC.) THEN WE WILL APPLY XEROFORM GAUZE WRAP AND WILL REPEAT TOMORROW, SUNDAY AND TO BE SEEN AGAIN MONDAY. APPLY SILVADENE CREAM TO THE AREA REWRAP WITH NOT STICK DRESSING. YOU WILL SEE THE PHOTOS AND HER SETTINGS F

  Patient problems: Blister; Partial thickness (Second Degree) Burn

  MAUDE report 22811862 ↗
• InjuryMar 13, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  ON 2/13/2025: OWNER OF THE CLINIC REACHED OUT TO SCITON'S CLINICAL SPECIALIST REQUESTING CLINICAL TREATMENT RECORDS ON A PATIENT. THE PROVIDER STATED THAT SHE HAD BURNED A PATIENT WITH BBL HEROIC ON BILATERAL ARMS. PATIENT FOLLOWED POST-CARE PROTOCOLS AND PROVIDED UPDATED PHOTOS TO THE PROVIDER. SILVADENE TOPICAL WAS APPLIED TO ARMS FOR SEVERAL DAYS POST-TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21602290 ↗
• InjuryMar 11, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  ON 2/13/25: SCITON CLINICIAN RECEIVED A VOICEMAIL FROM CLINIC OWNER. THE VOICEMAIL STATED THAT SHE HAD RECENTLY HAD A TWO-DAY PRECEPTORSHIP WITH A TRAINER NOT AFFILIATED WITH SCITON COVERING BBL HEROIC/ MOXI ON BBL (B)(6) 2025 AT HER PRACTICE. CLINIC OWNER STATED THAT SHE HAD CONCERNS WITH THE BBL TREATMENT RESULTS. CLINIC OWNER STATED THAT ONE OF HER PATIENTS REPORTED BURNS AND BLISTERS ON HER FACE FROM A BBL HEROIC PROCEDURE. SCITON CLINICIAN RECEIVED THIS VOICEMAIL AFTER HOURS AND WAS GOING TO BE OUT OF THE OFFICE THE FOLLOWING DAY, THEREFORE, SHE SENT THE VOICEMAIL TO SCITON CLINICAL SPECIALIST REQUESTING TO REACH OUT TO THE CUSTOMER DIRECTLY THE FOLLOWING MORNING. THE CLINIC OWNER RECOMMENDED PATIENT TO UTILIZE AQUAPHOR. CLINIC OWNER DID NOT PRESCRIBE AN RX FOR THE PATIENT, HOWEVER, THE CLINIC OWNER STATED THAT THE PATIENT WENT TO A DERMATOLOGIST AND WAS PRESCRIBED AN ANTIBIOTIC AND SHE IS UNAWARE OF WHAT ANTIBIOTIC WAS PRESCRIBED. THE CLINIC OWNER MAILED THE PATIENT SKIN CARE PRODUCTS INCLUDING ALASTIN SKIN NECTAR AND RECOVERY BALM.

  Patient problems: Blister; Partial thickness (Second Degree) Burn

  MAUDE report 21576530 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10/15/2024, SCITON RN CALLED CLINIC AESTHETICIAN FOLLOWING AN EMAIL NOTIFICATION REGARDING A CLIENT REPORTING A BURN/BLISTER FOLLOWING A BBL TREATMENT ON (B)(6) 2024 AT THE CLINIC. CLINIC AESTHETICIAN REPORTED THAT THE CLIENT STATED THE BURNS PROGRESSED INTO BLISTERS AT WHICH POINT THE CLIENT SOUGHT CARE FROM HER PHYSICIAN WHO PRESCRIBED SILVER SULFADIAZINE BID ON (B)(6) 2024.

  Patient problems: Blister; Partial thickness (Second Degree) Burn

  MAUDE report 20605267 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 08/12/2024: OWNER OF THE CLINIC CONTACTED SCITON REPRESENTATIVE REPORTING THAT THE PATIENT'S CHEST HAD BURN FOLLOWING MJOULE BBL HEROIC TRAINING ON (B)(6) 2024 WITH 515 NM FILTER. THE PATIENT IS A STAFF MEMBER (NURSE PRACTITIONER) WITH ALLEGEDLY SOME IMMUNOCOMPROMISED ISSUES WITH HER HEALTH.

  Patient problems: Burn(s)

  MAUDE report 20185367 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INFORMATION: SEX: MALE, AGE: 40'S, NATIONALITY: JAPANESE, SKIN TYPE: IV, FIRST TIME BEARD REMOVAL (NO PRIOR COSMETIC PROCEDURES), TREATMENT AREA: PHILTRUM, MODE: FOREVER BARE. TREATMENT DETAILS: THE NURSE PERFORMED THE TREATMENT UNDER DOCTOR'S DIRECTION. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT, A FIRST-TIME FACIAL HAIR REMOVAL CLIENT WITH NO PRIOR COSMETIC TREATMENT EXPERIENCE, UNDERWENT THE FACIAL HAIR REMOVAL PROCEDURE. ALTHOUGH THE PATIENT'S FACIAL HAIR WAS THOROUGHLY SHAVED, IT REMAINED QUITE DENSE. THE FOLLOWING SETTINGS WERE USED: MODE: STATIC, SKIN TYPE: IV, HAIR COLOR: BLACK, HAIR THICKNESS: COARSEST, HAIR DENSITY: HIGHEST, ADAPTER: 15×15, FILTER: 640NM (AS RECOMMENDED ON-SCREEN), ENERGY: 12 J/CM², PULSE DURATION: 25 MSEC, TEMPERATURE: 10 DEGREES, PASSES: 1, OVERLAP: APPROXIMATELY 50%, THE PATIENT EXPERIENCED PAIN DURING THE PROCEDURE, BUT HAD NO IMMEDIATE POST-TREATMENT SKIN PROBLEMS. POST-TREATMENT FOLLOW-UP: THREE DAYS POST-TREATMENT, THE PATIENT REPORTED BLISTERING IN ONE AREA OF THE PHILTRUM. BETAMETHASONE VALERATE WAS INITIATED, AND THE BLISTER HAS SINCE DISAPPEARED AND IS HEALING WELL.

  Patient problems: Blister

  MAUDE report 19515490 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDWATCH FORM, MW5146663, RECEIVED FROM FDA ON 10/26/2023. DESCRIPTION OF EVENT: DATE OF EVENT: (B)(6) 2023. "I WAS TREATED ON (B)(6) 2023 WITH SCITON MJOULE FOREVER YOUNG BBL (BROAD BAND LIGHT) HERO (HIGH ENERGY RAPID OUTPUT). THE TREATMENT WAS DIRECTED AT SOLAR LENTIGINES (SUN SPOTS) MOSTLY ON MY LEFT CHEEK BUT DIFFUSELY. I HAVE FPST III (FITZPATRICK SKIN TYPE 3). I DID NOT USE ANY RETINOID BEFORE TREATMENT AND HAD NO SUN EXPOSURE. I FOLLOWED ALL POST TREATMENT INSTRUCTIONS. TREATMENT PARAMETERS AS FOLLOWS: 515 NM FILTER: 1ST PASS: FLUENCE 6, PULSE WIDTH 3, RATE 4, CHILL TEMP 25C, TOTAL SHOTS 214; 2ND PASS: FLUENCE 6, PW 3, RATE 4, CHILL TEMP 25, TOTAL SHOTS 400 SPOT TREATMENT 7MM HANDPIECE, 515 NM FILTER, FLUENCE 12, PW 10, RATE 1, CHILL TEMP 20C, TOTAL SHOTS 654, SPOT TREATMENT 11 MM 515 NM FILTER, FLUENCE 12, PW 8, RATE 1, CHILL TEMP 20, TOTAL SHOTS 659 560 NM FILTER: 1ST PASS: FLUENCE 6, PW 3, RATE 4, CHILL TEMP 25, TOTAL SHOTS 860; 2ND PASS: FLUENCE 6, PW 3, RATE 4, CHILL TEMP 25, TOTAL SHOTS 993; SPOT TX 7MM, FLUENCE 20, PW 25, RATE 1, CHILL TEMP 20, TOTAL SHOTS 1054; SPOT TREATMENT: 7MM HANDPIECE, FLUENCE 12 , PW 10, RATE 1, CHILL TEMP 22, TOTAL SHOTS 1199. EYEPIECE WAS WO

  Patient problems: Blister; Blurred Vision; Distress; Hypersensitivity/Allergic reaction; Muscle Weakness/Atrophy; Pain; Skin Discoloration; Superficial (First Degree) Burn

  MAUDE report 18116769 ↗