MAUDE Adverse Event Report: THERABODY, INC. THERAFACE PRO; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

Multiple consumer complaints of theraface pro class ii medical device with the cold ring overheating causing potential for injury.Marketing directly from the website states "cold ring helps reduce puffiness under eyes.Decreases pain, inflammation, and muscle spasms" however if the cold ring doesn't produce a cooling effect, but a heating effect, then the marketing language is claiming incorrect information.Therabody refusing refunds and replacements.Bbb (better business bureau) rating is f.Reference report: mw5145021.

• Brand Name: THERAFACE PRO
• Type of Device: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• Manufacturer (Section D): THERABODY, INC.; 6100 wilshire blvd.; los angeles CA 90048
• MDR Report Key: 17642074
• MDR Text Key: 322385076
• Report Number: MW5145020
• Device Sequence Number: 1
• Product Code: OHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2023
• Patient Sequence Number: 1