InjuryONF
LUMARX
Received Apr 10, 2015 · Event occurred Mar 4, 2015
Report 3005855240-2015-00001 · MDR key 4698835
Device
Generic name
Light Based Hair Removal Device
Manufacturer
Shaser, IncModel number
IPL6800USAQCatalog number
IPL6800USAQ
Lot number
NA
Product problems
- Use of Device Problem
- Improper or Incorrect Procedure or Method
Patient
34 YR
- Scarring
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
USER TREATED HER FACE WITH IPL6800 HAIR REMOVAL DEVICE AND SUSTAINED FIRST AND SECOND DEGREE BURNS, POSSIBLY RESULTING IN PERMANENT DAMAGE TO HER SKIN IN THE FORM OF SCARRING. FROM THE COMPLAINT: "CONSUMER HAS LUMARX AND STATES SHE WAS BURNED TO THE POINT SHE HAD BLISTERS ON HER FACE FROM IT. STATED IT WAS RED AFTER IT WAS DONE WOKE UP THIS MORNING BLISTERED AND BLACK. LIKE CURLING IRON BURN. STATE SHE DID NOT TREAT THE SAME SPOT MORE THAN ONCE." REF MFR#: 3009088196-2015-00001.