MAUDE Adverse Event Report: SHARKNINJA OPERATING LLC SHARK CRYOGLOW; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION

Model Number	FW312
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545); Eye Irritation (4803)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted once investigation occurs.
Event or Problem Description
The customer reported red under her eyes and saw a medical professional that advised not to use the mask again and prescribed medication.

• Brand Name: SHARK CRYOGLOW
• Common Device Name: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• Manufacturer (Section D): SHARKNINJA OPERATING LLC; 89 a st #100; needham MA 02511
• Manufacturer (Section G): SHARKNINJA OPERATING LLC; 89 a st #100; needham MA 02511
• Manufacturer Contact: naisargi sheth ; 89 a st #100; needham, MA 02511
• MDR Report Key: 24507935
• Report Number: 3013738756-2026-00007
• Device Sequence Number: 10440669
• Product Code: OHS
• UDI-Device Identifier: 00622356642804
• UDI-Public: 00622356642804
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K242796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: FW312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female