BBLsRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00863249000312), received between May 21, 2024 and Jul 7, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  PATIENT: MALE, 50S SKIN TYPE: V. TREATMENT DATE: (B)(6) 2025. PERFORMED BY: NURSE. TREATMENT DETAILS: FULL-FACE TREATMENT. FILTER: 590. FLUENCE: 11 J/CM². PULSE WIDTH: 20 MSEC. COOLING TEMPERATURE: 15°C. ADAPTER: 15×15. PASSES: 1. SHOTS: 182. SPOT TREATMENT FOR MULTIPLE PIGMENTED LESIONS. FILTER: 560. FLUENCE: 15 J × 3 SHOTS. MODE: SPOT TREATMENT. SHOTS: 182. NUMEROUS PIGMENTED LESIONS. ADVERSE EVENT DESCRIPTION: NO DISCOMFORT WAS REPORTED DURING THE PROCEDURE. ON THE FOLLOWING DAY, BLISTER FORMATION OCCURRED ON THE RIGHT FOREHEAD AT THE LOCATION OF A DARK PIGMENTED LESION THAT HAD RECEIVED SPOT TREATMENT WITH THE 560 FILTER. THE PATIENT VISITED THE CLINIC THE FOLLOWING DAY, WHERE BETAMETHASONE VALERATE 0.12% (LINDELONE VC 0.12%) WAS APPLIED TOPICALLY. ADDITIONALLY, HYDROCORTISONE BUTYRATE 0.1% (LOCOID 0.1%) WAS PRESCRIBED FOR USE AT HOME. UPON FOLLOW-UP ON JUNE 18, THE LESION SHOWED SIGNIFICANT IMPROVEMENT WITH MINIMAL POST-INFLAMMATORY HYPERPIGMENTATION (PIH) AND NO VISIBLE SCARRING. PREVIOUS TREATMENT: PREVIOUS SESSION ON (B)(6), 2025. THE SAME PARAMETERS AS THOSE USED ON (B)(6), 2025, WERE APPLIED FOR FULL-FACE TREATMENT. PIGMENTED LESION SPOT TREATMENT AT THAT TIME USED THE 56

  Patient problems: Blister

  MAUDE report 22420639 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT: 70S AGE. PATIENT SKIN TYPE: IV. TREATMENT DATE: ON (B)(6) 2025. TREATMENT PERFORMED BY: NURSE. TREATMENT DETAILS: FULL-FACE TREATMENT. FILTER: 590. FLUENCE: 9 J/CM². PULSE WIDTH: 20 MSEC. COOLING: 15°C. ADAPTER: 15×15. SHOTS: 155. SPOT TREATMENT FOR PIGMENTED LESIONS. FILTER: 560. FLUENCE: INITIALLY 11 J. PULSE WIDTH: 15-20 MSEC. DUE TO PATIENT-REPORTED PAIN, FLUENCE WAS REDUCED TO 10 J DURING THE PROCEDURE. TOTAL SPOT TREATMENT SHOTS: 52. ADVERSE EVENT DESCRIPTION: IT WAS REPORTED THAT IMMEDIATELY AFTER THE PROCEDURE, INTENSE "POPPING" RESPONSES WERE OBSERVED ON THE HEAVILY PIGMENTED LESIONS TREATED WITH THE 560 FILTER. THOSE AREAS BECAME NOTICEABLY DARKER, AND BLISTER FORMATION OCCURRED. THE PATIENT WAS PRESCRIBED DEXAMETHASONE PROPIONATE 0.1% (MESADERM 0.1%), BUT NO FOLLOW-UP VISIT HAS TAKEN PLACE TO DATE. THE PREVIOUS TREATMENT ON (B)(6) 2025, USED THE SAME PARAMETERS. AFTER THAT SESSION, THE PATIENT REPORTED INCREASED PIGMENTATION. THE CAUSE WAS PRESUMED TO BE POST-TREATMENT SUN EXPOSURE AND/OR FRICTION, RESULTING IN PIH (POST-INFLAMMATORY HYPERPIGMENTATION).

  Patient problems: Blister

  MAUDE report 22420637 ↗
• InjuryMay 21, 2024Use of Device Problem; Use of Device Problem

  ON APR 23, 2024, THE FOLLOWING INFORMATION WAS REPORTED BY THE CLINIC TO SCITON CLINICAL SPECIALIST: PATIENT INFORMATION: AGE: 50. NATIONALITY: JAPANESE. SKIN TYPE: IV. INITIAL VISIT (NO PRIOR COSMETIC PROCEDURES). MEDICAL HISTORY: PAST MEDICAL HISTORY: NONE. PRESENT ILLNESS: NONE. TREATMENT WAS PERFORMED ON (B)(6) 2024: IT WAS REPORTED THAT BBL TREATMENT WAS ADMINISTERED BY THE PHYSICIAN FOR REJUVENATION PURPOSES, TARGETING LIVER SPOTS. 590NM, 10J, 20MSEC, 15°C, 15×45 - FULL FACE (LARGE AREA), 1 PASS, 50 SHOTS 640NM, 10J, 20MSEC, 15°C, 15×45 - LIVER SPOTS (CHEEKS, CHEEKBONES), 1 PASS, 20 SHOTS 590NM, 12J, 20MSEC, 15°C, 15×15 - FULL FACE (SMALL AREA), 1 PASS, 50 SHOTS TREATMENT WAS STARTED FROM THE RIGHT SIDE, WITH SLIGHT HEAT WAS FELT ON THE LEFT SIDE. NO COMPLAINTS OF PAIN OR HEAT SENSATION DURING THE PROCEDURE. PATIENT REPORTED EXPERIENCING TINGLING SENSATION ON THE ENTIRE FACE ON THE WAY HOME. FOLLOW-UP TREATMENTS WERE PERFORMED ON: ·(B)(6) 2024. PATIENT REPORTED BLISTER FORMATION (TIMING UNSPECIFIED). PATIENT VISITED A NEARBY DERMATOLOGY CLINIC ON (B)(6) 2024. DETAILS OF TREATMENT ARE UNCLEAR. ·(B)(6) 2024. PATIENT REPORTED A LINEAR 3CM BLISTER RESIDUE ON THE LEFT CHEEKBONE, W

  Patient problems: Blister; Hyperpigmentation

  MAUDE report 19367981 ↗
• InjuryMay 21, 2024Use of Device Problem; Use of Device Problem

  ON APR 23, 2024, THE FOLLOWING INFORMATION WAS REPORTED BY THE CLINIC TO SCITON CLINICAL SPECIALIST: PATIENT INFORMATION: AGE: 45 NATIONALITY: JAPANESE SKIN TYPE: IV INITIAL VISIT (NO PRIOR COSMETIC PROCEDURES). MEDICAL HISTORY: PAST MEDICAL HISTORY: NONE PRESENT ILLNESS: NONE TREATMENT WAS PERFORMED ON (B)(6) 2024: BBL TREATMENT WAS ADMINISTERED BY THE PHYSICIAN FOR OVERALL FACIAL REJUVENATION AND IMPROVEMENT OF PIGMENTATION. 590NM, 8J, 20MSEC, 15°C, 15×45 - FULL FACE (LARGE AREA), 1 PASS, 60 SHOTS 590NM, 10J, 20MSEC, 15°C, 15×15 - FULL FACE (SMALL AREA), 1 PASS, 40 SHOTS 515NM, 15J, 10MSEC, 20°C, 7MM - SPOT TREATMENT FOR PIGMENTATION, 60 SHOTS. TREATMENT STARTED FROM THE RIGHT SIDE, WITH SLIGHT HEAT FELT ON THE LEFT SIDE. NO COMPLAINTS OF PAIN OR HEAT SENSATION DURING THE PROCEDURE, BUT PATIENT REPORTED FLUSHING AND TINGLING SENSATIONS POST-PROCEDURE. FOLLOWING THE BBL TREATMENT, IONTOPHORESIS (VITAMIN C) WAS ADMINISTERED. SUBSEQUENTLY, THE PATIENT REPORTED BLISTER FORMATION DURING FACE WASHING (BETWEEN THE LEFT NOSE AND CHEEKBONE). IT WAS REPORTED THAT THE TREATMENT INCLUDED COOLING, APPLICATION OF DESONIDE CREAM ON THE LEFT SIDE AND LINDANE CREAM (BETAMETHASONE VALERATE GENTAMI

  Patient problems: Blister

  MAUDE report 19367980 ↗