InjuryOHS
SHARK CRYOGLOW
Received Jun 29, 2026 · Event occurred Jan 3, 2026
Report 3013738756-2026-00040 · MDR key 25656684
Device
Generic name
Light Based Over The Counter Wrinkle Reduction
Manufacturer
Sharkninja Operating LlcModel number
FW312UKProduct problems
- Insufficient Device Problem Information
Patient
NA · Female
- Skin Discoloration
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED SKIN IRRITATION, REDNESS AND SORENESS UNDER THE EYE. GP ADVISED STOPPING USING MASK AND PRESCRIBED USING AN EMOLLIENT.
Additional Manufacturer Narrative
THE EVENT WAS NOT REPORTED WITHIN THE REQUIRED REPORTING TIMEFRAME DUE TO DELAYED INTERNAL ESCALATION. UPON IDENTIFICATION, THE COMPLAINT WAS IMMEDIATELY EVALUATED FOR REPORTABILITY AND SUBMITTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION OCCURS.