InjuryOHS
SHARK CRYOGLOW
Received Jun 29, 2026 · Event occurred Apr 22, 2026
Report 3013738756-2026-00039 · MDR key 25656301
Device
Generic name
Light Based Over The Counter Wrinkle Reduction
Manufacturer
Sharkninja Operating LlcModel number
FW312PLProduct problems
- Insufficient Device Problem Information
Patient
NA · Female
- Erythema
- Skin Inflammation/ Irritation
- Dry Skin
Narrative
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.
Description of Event or Problem
THE CUSTOMER REPORTED SKIN IRRITATION AND CYSTIC ACNE ON THEIR FACE AND NECK. GP ADVISED TO STOP USING THE MASK.