MAUDE Adverse Event Report: CURRENTBODY LTD. CURRENTBODY SKIN LED LIGHT THERAPY FACE MASK; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION

Model Number	MK66R-B
Health Effect - Clinical Codes	Rash (2033); Superficial (First Degree) Burn (2685); Blister (4537)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
I used led mask after using tretinoin.It caused rash, burn and blisters on my cheeks.That was not clearly labeled in the warning section.

• Brand Name: CURRENTBODY SKIN LED LIGHT THERAPY FACE MASK
• Common Device Name: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• Manufacturer (Section D): CURRENTBODY LTD.
• MDR Report Key: 17388886
• Report Number: MW5119982
• Device Sequence Number: 13761194
• Product Code: OHS
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

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
• Device Model Number: MK66R-B
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRETINOIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian