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

Model Number	FW312UKPL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event occurred with a similar device in a foreign market and was not initially determined to be reportable in the us.After review and determination that the event met the criteria for us reportability this report is being submitted without undue delay.
Event or Problem Description
The customer states that the mask caused damage to her skin and that she has marks on her face.She states that she had to seek out medical attention for the red marks because she still had them 24 hours after using the mask with the cooling pads off and four days after using the mask with the cooling pads on.

• 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 02494
• Manufacturer (Section G): SHARKNINJA OPERATING LLC; 89 a st #100; needham MA 02494
• Manufacturer Contact: chirag shah ; 89 a st #100; needham, MA 02494
• MDR Report Key: 21756403
• Report Number: 3013738756-2025-00007
• Device Sequence Number: 12987853
• 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): 04/02/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: FW312UKPL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2025
• Initial Report FDA Received Date: 04/02/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female