ULTRASLIM DIGITAL
Received Mar 30, 2023 · Event occurred Mar 17, 2023
Report 3010053-2023-00004 · MDR key 16643299
Device
Generic name
Fat Reducing Low Level Laser
Manufacturer
Ward PhotonicsModel number
60008Catalog number
60008
Lot number
230109-01
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Superficial (First Degree) Burn
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
ALLEGED BLISTERS / RASH ON PATIENT SKIN FOLLOWING RED LIGHT TREATMENT. PATIENT CLAIMS TO HAVE BEEN "BURNED." NOTE THAT BLISTERS WERE FOUND UNDER CLOTHING, AND NOT IN AREAS OF DIRECT EXPOSURE TO THE LIGHT.
Additional Manufacturer Narrative
PATIENT CLAIMS TO HAVE BEEN BURNED UNDERNEATH HER UNDERWEAR BY THE LIGHT. SHE HAS SINCE SOUGHT MEDICAL TREATMENT FOR THE ALLEGED "BURN." THE RESULTS OF THE MEDICAL EXAM ARE NOT KNOWN TO US. NOTE THAT THE AFFECTED AREA WAS UNDERNEATH CLOTHING AND NOT DIRECTLY IN THE LIGHT. ALSO NOTE THAT THE APPARENT "BLISTERS" APPEAR TO BE MORE SIMILAR TO SOME TYPE OF A SKIN INFECTION. DEVICE WAS INSPECTED BY MANUFACTURER AND ALL SPECIFICATIONS ARE WITHIN REQUIREMENTS.