inforMED
InjuryONF

I-LIGHT PRO

Received Oct 28, 2016 · Event occurred Sep 20, 2016

Report 3005855240-2016-00005 · MDR key 6064174

Device

Generic name

Ipl6000

Manufacturer

Shaser Inc

Model number

IPL6000

Catalog number

IPL6000

Lot number

40

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

46 YR

  • Burn(s)
  • Burn, Thermal
  • Partial thickness (Second Degree) Burn
  • Burn(s)
  • Burn, Thermal
  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

CONSUMER EXPERIENCED BURNS ON LEG AFTER USING DEVICE. DEVICE HAD PREVIOUSLY BEEN USED WITH NO ISSUE. TESTING WAS COMPLETED ON RETURNED UNIT AND THE ENERGY-LEVEL OF THE FLASH OUTPUT WAS PROFILED WITH THE ORIGINAL AND TEST REPLACEMENT CARTRIDGES. THERE WAS NO OBSERVED DEVIANCE FROM THE PRODUCT PERFORMANCE SPECIFICATION.