InjuryONF
ILIGHT PRO PLUS QUARTZ
Received Sep 29, 2016 · Event occurred Apr 29, 2016
Report 3005855240-2016-00003 · MDR key 5988737
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
22 YR
- Burn(s)
- Burn, Thermal
- Partial thickness (Second Degree) Burn
- Burn(s)
- Burn, Thermal
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
INITIAL EVALUATION FOR REPORTABILITY WAS LISTED AS NOT REPORTABLE DUE TO SEVERITY OF INJURY. UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THIS MAY BE CLASSIFIED AS A SERIOUS INJURY AND REPORTABLE.
Description of Event or Problem
CONSUMER USED PRODUCT AND REPORTED THAT IT BURNED HER SKIN. TRIED TWICE AND IT LEFT BLISTERS THE SECOND TIME.