Description of Event or Problem · 0
ON (B)(6) 2023, I SUSTAINED SEVERE BURNS DURING A COSMETIC LASER HAIR REMOVAL PROCEDURE PERFORMED AT (B)(6). THE DEVICE IN USE WAS MANUFACTURED BY BEIJING JONTE TECHNOLOGY CO., LTD. (CHINA) AND WAS LABELED AS A "VACUUM CLEANER" (MODEL: T8PRO, POWER: 4000W). DESPITE THE LABEL, THE DEVICE WAS CLEARLY MARKETED AND USED AS A LASER HAIR REMOVAL MACHINE ON PATIENTS. THE PROCEDURE CAUSED IMMEDIATE PAIN, BLISTERING, AND SUBSEQUENT SCARRING THAT REQUIRED ONGOING DERMATOLOGICAL CARE. MY RECOVERY REQUIRED MEDICAL INTERVENTION TO PREVENT PERMANENT HARM, AND I CONTINUE TO EXPERIENCE LASTING SKIN DAMAGE. THIS APPEARS TO BE A CASE OF DELIBERATE PRODUCT MISLABELING INTENDED TO EVADE FDA (FOOD & DRUG ADMINISTRATION) MEDICAL DEVICE APPROVAL AND U.S. CUSTOMS DUTIES. THE DEVICE WAS NOT REPRESENTED AS A MEDICAL DEVICE ON ITS LABEL, YET IT WAS USED ON PATIENTS IN A CLINICAL SETTING WITHOUT PROPER FDA CLEARANCE OR SAFETY EVALUATION. THE MISLABELED DEVICE POSES A SERIOUS AND ONGOING RISK TO U.S. CONSUMERS. IT WAS OPERATED BY STAFF WHO LACKED ADEQUATE TRAINING, AND THE MANUFACTURER'S LABELING PROVIDED NO ACCURATE INFORMATION ABOUT MEDICAL USE, RISKS, OR SAFETY PROTOCOLS. I REQUEST FDA INVESTIGATE THIS DEVICE FOR: USE OF NON-APPROVED, MISLABELED EQUIPMENT IN A MEDICAL/COSMETIC SETTING PATIENT INJURY DUE TO BURNS AND SCARRING FAILURE TO PROVIDE ACCURATE LABELING, WARNINGS, OR INSTRUCTIONS RISK OF ONGOING HARM TO OTHER PATIENTS SUPPORTING DOCUMENTS, PHOTOS, AND VIDEO EVIDENCE ARE AVAILABLE TO DEMONSTRATE BOTH THE MISLABELED PRODUCT AND THE INJURIES SUSTAINED. PATIENT SUSTAINED BURN INJURIES FROM USE OF A COSMETIC LASER HAIR REMOVAL DEVICE ON (B)(6) 2023. THE DEVICE WAS IDENTIFIED AT THE (B)(6) AS A "(B)(6)," LATER CONFIRMED TO BE A UNIT MANUFACTURED BY BEIJING JONTE TECHNOLOGY CO., LTD. (CHINA), WITH PRODUCT LABELING MISCLASSIFIED AS "VACUUM CLEANER." DERMATOLOGY EVALUATIONS ON (B)(6) 2023 DOCUMENTED MULTIPLE HYPOPIGMENTED BURN SCARS ACROSS BOTH UPPER EXTREMITIES, INCLUDING THE RIGHT DISTAL/PROXIMAL FOREARM, RADIAL DORSAL FOREARM, LEFT FOREARM, UPPER ARMS, AND POSTERIOR REGIONS. PHOTOS CONFIRM MOTTLED SCARRING CONSISTENT WITH LASER BURNS. CLINICAL ASSESSMENTS DESCRIBE: CHIEF COMPLAINT: SCARS SECONDARY TO LASER HAIR REMOVAL BURNS. EXAM FINDINGS: PERMANENT HYPOPIGMENTED PATCHES, HYPERTROPHIC SCARRING, MODERATE SEVERITY, REQUIRING ONGOING TREATMENT. TREATMENT PROVIDED: TOPICAL CORTICOSTEROIDS (TRIAMCINOLONE ACETONIDE 0.1%), TOPICAL CALCINEURIN INHIBITOR (TACROLIMUS 0.1%), SILICONE GEL SHEETS, SUN PROTECTION, AND COUNSELING. OUTCOME: PERSISTENT SCARS >2 MONTHS POST-EXPOSURE. ONGOING MANAGEMENT REQUIRED. ATTACHED RECORDS INCLUDE PROVIDER NOTES AND PHOTOGRAPHIC DOCUMENTATION CONFIRMING INJURY DIRECTLY CAUSED BY THE DEVICE. PATIENT REQUIRED MEDICAL INTERVENTION TO PREVENT PERMANENT WORSENING AND CONTINUES UNDER DERMATOLOGIC CARE.