BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAFACE PRO

    MDR report key: 17642081 · Received August 28, 2023

    Report

    Report Number
    MW5145021
    Event Type
    Other
    Date Received
    August 28, 2023
    Report Date
    August 28, 2023
    Manufacturer
    THERABODY, INC.
    Product Code
    OLP
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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: MW5145020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438930 THERAFACE PRO OVER-THE-COUNTER POWERED LIGHT BASED LASER FOR ACNE OLP THERABODY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown