BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAFACE PRO COLD RING

    MDR report key: 17239943 · Received June 29, 2023

    Report

    Report Number
    MW5119024
    Event Type
    Other
    Date Received
    June 29, 2023
    Report Date
    June 29, 2023
    Manufacturer
    THERABODY, INC.
    Product Code
    IME
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPEATED ONLINE COMPLAINTS OF THE COLD RING OVERHEATING AND BECOMING DANGEROUSLY HOT. MULTIPLE CONSUMERS COMPLAINING THAT WITH A (B)(6) PRICE TAG, CUSTOMER SERVICE REFUSES ANY REFUNDS, INVESTIGATIONS INTO THE PRODUCT'S SAFETY, OR REPLACEMENT. PER THEIR WEBSITE "COLD RING HELPS REDUCE PUFFINESS UNDER EYES. DECREASES PAIN, INFLAMMATION, AND MUSCLE SPASMS" HOWEVER THIS IS FALSE ADVERTISING IF THE RING OVERHEATS AND BECOMES TOO HOT TO TOUCH. SAFETY CONCERNS SENT IN WRITING TO THERABODY. AMAZON COMPLAINTS, COMMENTS ON SOCIAL MEDIA WITH ALL THE SAME COMPLAINT WITH THERABODY TAGGED. THERABODY IS AWARE THAT THIS IS AN ISSUE, AND NOT ONLY CONTINUES TO SELL THE DEVICE BUT REFUSES TO REFUND ANYONE WHO HAS THE COMPLAINT. I HAVE THE DEVICE, AND THE COLD RING BECOMES DANGEROUSLY HOT ALMOST BURNING MY SKIN. I WAS REPEATEDLY IGNORED BY CUSTOMER SERVICE. IN SEARCHING, I FOUND THAT I AM ONE OF MANY WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255245 THERAFACE PRO COLD RING PACK, HOT OR COLD, REUSABLE IME THERABODY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown