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

Model Number MK66R-B

Patient Problems Rash (2033); Superficial (First Degree) Burn (2685); Blister (4537)

Event Date 07/17/2023

Event Type  Injury  

Event 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
• Type of Device: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• Manufacturer (Section D): CURRENTBODY LTD.
• MDR Report Key: 17388886
• MDR Text Key: 319789438
• Report Number: MW5119982
• Device Sequence Number: 1
• Product Code: OHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• 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
• Patient Sequence Number: 1
• Treatment: TRETINOIN
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian