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

Patient Problems Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)

Event Date 05/02/2024

Event Type  Injury  

Event 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
• Type of Device: STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
• Manufacturer (Section D): FOREO, INC.
• MDR Report Key: 19373925
• MDR Text Key: 343308182
• Report Number: MW5155226
• Device Sequence Number: 1
• Product Code: NFO
• 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: 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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2024
• Patient Sequence Number: 1
• Treatment: BIOTIN.; MULTIVITAMIN.; TRAZADONE FOR SLEEP.; VITAMIN E.; VITAMIN K. ; VITAMINS.
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Hispanic
• Patient Race: White