inforMED
InjuryONF

I-LIGHT PRO IPL6500

Received Aug 25, 2016 · Event occurred Jul 21, 2016

Report 3005855240-2016-00002 · MDR key 5903365

Device

Generic name

Ipl6500

Manufacturer

Shaser Inc

Model number

IPL6500

Catalog number

IPL6500

Lot number

13

Product problems

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

Patient

24 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 USED IT WHEN SHE RECEIVED IT, AND THEN 2 WEEKS LATER AS INSTRUCTED. DURING THIS SECOND USE, SHE NOTICED A SPOT ON THE CAP / HEAD. SHE ALSO NOTICED A BURN MARK ON HER LEG, THAT APPEARS TO BE RELATED TO THE SPOT ON THE CAP.

Description of Event or Problem

CONSUMER USED IT WHEN SHE RECEIVED IT, AND THEN 2 WEEKS LATER AS INSTRUCTED. DURING THIS SECOND USE, SHE NOTICED A SPOT ON THE CAP / HEAD. SHE ALSO NOTICED A BURN MARK ON HER LEG, THAT APPEARS TO BE RELATED TO THE SPOT ON THE CAP.