InjuryOLI
ULTRASLIM
Received Nov 22, 2022 · Event occurred Sep 13, 2021
Report 3010053203-2022-00001 · MDR key 15847882
Device
Generic name
Fat Reducing Low Level Laser
Manufacturer
Ward PhotonicsModel number
60001Catalog number
60001
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
RECEIVED A VERBAL REPORT OF A PATIENT WHO HAD ALLEGEDLY BEEN BURNED DURING TREATMENT THE PRIOR YEAR. THE HEALTHCARE PROVIDER MENTIONED THE INCIDENT TO AN EMPLOYEE OF MANUFACTURER IN CONTEXT WITH ANOTHER TOPIC, AND THE INCIDENT WAS OVER ONE YEAR OLD. NO FURTHER INFORMATION ABOUT WHETHER THE BURN WAS EVER CONFIRMED BY A HEALTH CARE PROFESSIONAL OR NOT.
Description of Event or Problem
RECEIVED THIRD PERSON VERBAL REPORT OF A PATIENT WHO ALLEGEDLY WAS BURNED DURING TREATMENT.