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	Erythema (1840); Skin Discoloration (2074); Dry Skin (4839)
Date of Event	02/17/2026
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 with redness and dry skin arorund the nose and mouth.Gp advised to stop using the mask and prescribed various creams products for the skin dryness.

• 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: 24643460
• Report Number: 3013738756-2026-00009
• Device Sequence Number: 15921811
• 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): 03/19/2026

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
• Device Model Number: FW312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female