BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT HEAT THERAPY AIR

    MDR report key: 1000375 · Received February 20, 2008

    Report

    Report Number
    MW4004333
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    March 2, 2007
    Report Date
    February 12, 2008
    Manufacturer
    *
    Product Code
    IMD
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I INFORMED CHATTEM, BACK IN 2007, THAT THIS PRODUCT BURNT MY SON'S LEGS, SENT IN PICTURES AND A LETTER. THEY ALSO HAD ME MAIL THE PRODUCT BACK. FOLLOWING THAT TIME, I'VE TRIED TO CONTACT THEM NUMEROUS TIMES TO FIND OUT WHAT THEIR QA DEPT FOUND WRONG WITH THE PRODUCT. I WAS TOTALLY IGNORED FOR NOW A YEAR. MY EMAIL ADDRESS WOULD NO LONGER WORK AND ALL YOU EVER GET IS A VOICE RECORDING WHEN YOU CALL. THIS PRODUCT SHOULD HAVE BEEN PULLED A GOOD WHILE BACK, IT WAS AND IS HIGHLY DANGEROUS FOR YOUNG, MIDDLE AND THE ELDERLY WHICH I STATED IN MY LETTER TO THEM. DOSE OR AMOUNT: 1 PATCH PER LEG. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: SORE MUSCLES - RUNNING TRACK AND SOCCER. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY AIR * IMD * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention