MAUDE Adverse Event Report: FOREO, INC. BEAR 2 MICRO CURRENT; STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES

Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
I used the foreo bear 2 device 2x as indicated on the r side of my face, as it was the side i felt needed more "toning".As a result i have deep hollows and sagging skin from subcutaneous fat loss, which foreo markets as "safe" and states on its product that it exercises muscles and does not cause permanent loss of subcutaneous fat in the face.I have photos to show before & after as well as the great discrepancy between the two sides of my face.I have permanent damage to my face.

• Brand Name: BEAR 2 MICRO CURRENT
• Common Device Name: STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
• Manufacturer (Section D): FOREO, INC.
• MDR Report Key: 19373925
• Report Number: MW5155226
• Device Sequence Number: 19171616
• Product Code: NFO
• 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): 05/17/2024

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOTIN.; MULTIVITAMIN.; TRAZADONE FOR SLEEP.; VITAMIN E.; VITAMIN K. ; VITAMINS.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Hispanic
• Patient Race: White