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

Model Number	FW312UK
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event occurred with a similar device in a foreign market.A supplemental report will be submitted once invesgtigation occurs.
Event or Problem Description
The customer reported redness, irritation, and a burning sensation believed to be caused by the led lights.She stated that the mask "shocks the skin" and feels unsafe.

• 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
• Manufacturer (Section G): SHARKNINJA OPERATING LLC; 89 a st #100; needham MA
• Manufacturer Contact: chirag shah ; 89 a st #100; needham, MA
• MDR Report Key: 22160931
• Report Number: 3013738756-2025-00024
• Device Sequence Number: 17152735
• Product Code: OHS
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: FW312UK
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/06/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female