inforMED
InjuryONF

BBL (BROADBAND LIGHT) AND HALO

Received Dec 18, 2025 · Event occurred Mar 11, 2025

Report MW5180772 · MDR key 23837625

Device

Generic name

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

Manufacturer

Sciton, Inc.

Product problems

  • Patient-Device Incompatibility
  • Patient-Device Incompatibility

Patient

53 YR · Female

  • Superficial (First Degree) Burn
  • Blister
  • Swelling/ Edema
  • Hyperpigmentation
  • Hypopigmentation
  • Atrophy
  • Superficial (First Degree) Burn
  • Blister
  • Swelling/ Edema
  • Hyperpigmentation
  • Hypopigmentation
  • Atrophy

Narrative

Description of Event or Problem

I WENT IN TO GET A MEDICAL/COSMETIC PROCEDURE, AND THE DOCTOR USED EQUIPMENT AND I WAS BURNED. I REPEATEDLY REACHED OUT TO CLINIC OVER THE COURSE OF THE WEEK AFTER FROM (B)(6) 2025. I WAS TOLD EACH TIME THAT THIS WAS NORMAL AND I WAS HEALING IN THE RIGHT DIRECTION. I HAD EXTREME SWELLING ON MY FACE WHERE I COULDN'T OPEN MY EYES, I WAS SO SWOLLEN I WAS UNRECOGNIZABLE, COVERED IN BLISTERS. I REACHED OUT A FINAL TIME AND THE DOCTOR WAS THEN STATING THAT IT WAS NOT NORMAL, SHE STATED SHE HADN'T SEEN MY PICTURES I WAS SENDING THROUGH PORTAL KIARA SINCE (B)(6) 2025 WHICH CONTRADICTED PREVIOUS VOICEMAILS SHE HAD LEFT ON MY PHONE. THE DOCTOR'S RETURNED CALL WAS ACCUSATORY NATURE, WHEREAS SHE BLAMED ME FOR POTENTIALLY NOT DISCLOSING ANY UNDERLYING CONDITIONS, IN WHICH I DEFENDED MYSELF AS I HAD NONE. THEN SHE PRESCRIBED STEROIDS AND AN ANTIBIOTIC, ONCE I COULD OPEN MY EYES, I DROVE MYSELF TO THE HOSPITAL EMERGENCY, THE DID A FULL BLOOD PANEL AND I WAS EXAMINED, THEY NOTED MY BLISTERS AND BURNS AND DISCHARGED ME, STATING THERE WAS NO UNDERLYING CONDITIONS. THE ONLY THING MY BLOODWORK SHOWED WAS INDICATIVE OF THE BURN I SUSTAINED. I HAVE SINCE HAD A LENGTHY RECOVERY AS THE BURNS WERE ON MY FACE, AND I HAVE BEEN UNABLE TO BE EXPOSED TO SUN, I HAVE SCARS, HYPERPIGMENTATION, HYPOPIGMENTATION, ATROPHY, AND LASER BURN GRID MARKS. I FILED AN INCIDENT REPORT WITH MANUFACTURER, I HAVE THE COPIES OF THE EMAILS, THEY DENY THEIR EQUIPMENT WAS THE CAUSE, AND SUGGESTED THE SETTINGS USED BY PROVIDER WERE WHAT CAUSED THE BURN. I EMAILED TO GET MORE INFORMATION ABOUT SETTINGS AND GUIDELINES AND THE MANUFACTURER DENIES EVER BEING IN CONTACT WITH ME, ALTHOUGH I HAD SAVED THE EMAIL CORRESPONDENCE. I REACHED THE CLINIC AND WAS TOLD I WOULD BE SEEING THE DOCTOR AND THEY DID NOT KEEP THE APPOINTMENT AND SENT A NURSE PRACTITIONER INTO VISIT WITH ME, AFTER THE DOCTOR REMOVED PORTAL COMMUNICATIONS AND DELETED MY KLARA PORTAL FOLLOWING THE VISIT TO HOSPITAL DISCHARGE (B)(6) 2025 , I SOUGHT CARE WITH ANOTHER PROVIDER AT THAT POINT. I HAVE HAD MULTIPLE DOCTOR VISITS, AND TOPICAL PRP (PLATELET-RICH PLASMA) TREATMENTS TO REDUCE INFLAMMATION AND AID IN HEALING MY SKIN OVER 10 MONTHS POST PROCEDURE. I WOULD LIKE TO REPORT THIS AS I HAVE HAD PERMANENT DAMAGE TO MY FACE, AND I AM CERTAIN THIS WAS HANDLED INCORRECTLY BY BOTH PROVIDER AND MANUFACTURER. I ASKED MANUFACTURER TO PROVIDE PROTOCOL AND GUIDELINES AND THE SETTING STANDARDS, AS WELL AS INTERNAL CASE REVIEW AND THEY DENIED EVEN SPEAKING TO ME, ALTHOUGH I HAVE THE EMAILS AND CALLS RECORDED. I ALSO HAVE PROOF OF MY INJURIES AND MEDICAL DOCUMENTS. I HAVE PICTURES DAILY SINCE THIS HAPPENED, I HAVE THE ER PICTURES AND MY DOCTORS HAVE DOCUMENTED AND TAKEN PHOTOS. PT CODES: 2685, 4577, 4537, 4837, 4838, 4913. DEVICE CODE: 2682. REF REPORT: MW5180771.