InjuryOKJ
VIRULITE
Received Apr 23, 2019 · Event occurred Apr 17, 2019
Report MW5086121 · MDR key 8546304
Device
Generic name
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Manufacturer
Virulite LlcProduct problems
- Patient-Device Incompatibility
Patient
68 YR
- Burn, Thermal
- Burn, Thermal
Narrative
Description of Event or Problem
I USED THE VIRULITE DEVICE AS INSTRUCTED ON MY UPPER LIP TWICE ON (B)(6) 2019 AT ABOUT 9AM AND 7PM. I WOKE THE NEXT DAY WITH SEVERE BURN FROM THE BOTTOM OF MY NOSE TO THE TOP OF MY LIP. MY COLD SORE HAD SPREAD ACROSS MY TOP LIP AND TO MY BOTTOM LIP. THE BURN EXTENDED INTO MY RIGHT NOSTRIL. FDA SAFETY REPORT ID # (B)(4).