InjuryOHS
SHARK CRYOGLOW
Received Jul 3, 2026 · Event occurred Apr 24, 2026
Report 3013738756-2026-00042 · MDR key 25708589
Device
Generic name
Light Based Over The Counter Wrinkle Reduction
Manufacturer
Sharkninja Operating LlcModel number
FW312UKProduct problems
- Insufficient Device Problem Information
Patient
Not reported
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED ENLARGED PORES AFTER USING MASK. MEDICAL PRACTIONER ADVISED TO STOP USING THE MASK AND THE TREATMENT.
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.