InjuryOHS
SHARK CRYOGLOW
Received Jul 10, 2026 · Event occurred May 14, 2026
Report 3013738756-2026-00043 · MDR key 25780768
Device
Generic name
Light Based Over The Counter Wrinkle Reduction
Manufacturer
Sharkninja Operating LlcModel number
FW312UKProduct problems
- Insufficient Device Problem Information
Patient
Not reported
- Ecchymosis
- Erythema
- Skin Discoloration
- Eye Irritation
Narrative
Additional Manufacturer Narrative
A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION OCCURS.
Description of Event or Problem
THE CUSTOMER REPORTED DARK DISCOLARATION AND BRUSING ON THEIR FACE AFTER USING THE MASK. OPTOMETRIST CONFIRMED AND ASKED TO STOP USING THE MASK.