BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "ICY HOT"

    MDR report key: 1001426 · Received February 19, 2008

    Report

    Report Number
    MW5005596
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    February 16, 2008
    Report Date
    February 19, 2008
    Manufacturer
    CHATTEM
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED "ICY HOT" PRODUCT ON LOWER BACK. SUSTAINED SEVERE BURNS AND SKIN WAS RIPPED OFF WHEN PRODUCT WAS REMOVED. DATES OF USE: 2008 FOR 8 HOURS. DIAGNOSIS OR REASON FOR USE: SORE LOWER BACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other| R