BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEAR 2 MICRO CURRENT

    MDR report key: 19373925 · Received May 21, 2024

    Report

    Report Number
    MW5155226
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 17, 2024
    Manufacturer
    FOREO, INC.
    Product Code
    NFO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299003 BEAR 2 MICRO CURRENT STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES NFO FOREO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other BIOTIN.| MULTIVITAMIN.| TRAZADONE FOR SLEEP.| VITAMIN E.| VITAMIN K. | VITAMINS.