ULTRASLIM DIGITAL
Received Jan 6, 2023 · Event occurred Dec 5, 2022
Report 3010053203-2023-00001 · MDR key 16116993
Device
Generic name
Fat Reducing Low Level Laser
Manufacturer
Ward PhotonicsModel number
60008Catalog number
60008
Lot number
211112-03
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
50 YR · Female
- Superficial (First Degree) Burn
- Superficial (First Degree) Burn
Narrative
Additional Manufacturer Narrative
AN ALLEGED INCIDENT WAS REPORTED BY A DR (B)(6) ON (B)(6) 2022 TO WARD PHOTONICS TECHNICAL SUPPORT IN WHICH A FEMALE PATIENT CLAIMS SHE DEVELOPED A "BURN-LIKE BLISTER" AFTER AN A SERIES OF 4, EIGHT-MINUTE TREATMENTS. NO DOCTOR REPORT WAS PROVIDED TO THE DOCTOR NOR THE MANUFACTURER (WP). ACCORDING TO DOCTOR, CLIENT DID NOT WANT TO BE CONTACTED FURTHER. NOTE: PATIENT CONTINUED TO BE TREATED, WITHOUT-ISSUE, FOR OVER A MONTH AFTER ALLEGED INCIDENT (AS OF ON (B)(6) 2023). ACCORDING TO DOCTOR- THE PATIENT IS UNAWARE WHY THERE WAS A TEMPORARY-INJURY DURING A SINGULAR TREATMENT-WITHOUT REAPPEARING BEFORE OR SINCE. DR CLAIMS PATIENT IS CONTINUALLY HAPPY WITH RESULTS SEEN.
Description of Event or Problem
PATIENT CLAIMS TO HAVE RECEIVED BURN DURING LLLT TREATMENT USING RED LED COLD LIGHT. HOWEVER, THE DOCTOR WAS NOT ABLE TO CONFIRM THAT IT WAS A BURN, OR THAT IT OCCURRED AS A RESULT OF LLLT TREATMENT.
Remedial action
- Inspection