InjuryOHS
SHARK CRYOGLOW
Received Jul 2, 2026 · Event occurred May 5, 2026
Report 3013738756-2026-00037 · MDR key 25697412
Device
Generic name
Light Based Over The Counter Wrinkle Reduction
Manufacturer
Sharkninja Operating LlcModel number
FW312PLProduct problems
- Insufficient Device Problem Information
Patient
Not reported
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION OCCURS.
Description of Event or Problem
THE CUSTOMER REPORTED WITH SKIN IRRITATION AND PUFFINESS ON CHEEK AND EYE AREA . GP ADVISED TO STOP USING MASK.