BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT PATCH MENTHOL 5%

    MDR report key: 1000333 · Received February 16, 2008

    Report

    Report Number
    MW5005550
    Event Type
    Injury
    Date Received
    February 16, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 16, 2008
    Manufacturer
    CHATTEM
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS APPEARS TO BE A DIFFERENT CHATTEM ICY HOT PRODUCT FROM THE RECALL BUT IT MAY NEED TO BE ADDED TO THE LIST. IN 2008 AT 7:43PM, I PURCHASED 1 ICY HOT PATCH 5 CT FROM A PHARMACY. THAT NIGHT, THE SAME DAY, I APPLIED A PATCH FOR APPROX 6 HOURS FOR BURSITIS PAIN. AFTERWARDS, I HAD LESS PAIN IN MY ARM SO ON THE NEXT DAY, I APPLIED ANOTHER OF THE PATCHES FOR APPROX 6 HOURS AT A SLIGHTLY DIFFERENT PLACE ON MY ARM. WHEN I REMOVED IT, I HAD SEVERAL PURPLISH SPOTS WHERE THE PATCH HAD BEEN. I ALSO DID NOT FEEL WELL. I DID NOT USE ANY MORE BECAUSE I THOUGHT IT WAS AN ALLERGIC REACTION. LATER IN THE WEEK, I WAS TOLD BY A COUPLE OF PEOPLE THAT IT WAS BURNS AND THAT THERE HAD BEEN A RECALL ON THE PRODUCT. THE SPOTS ARE NOW FADING BUT I AM VERY CONCERNED THAT BECAUSE OF THE BURNS, SOME OF THE MEDICATION COULD HAVE SEEPED INTO MY BLOOD STREAM OR CAUSED OTHER PROBLEMS WHICH MAY SURFACE LATER. I HAVE BEEN PROVIDED PATCHES BY TWO OTHER HEALTH PROFESSIONALS BUT EACH TOLD ME, IN NO UNCERTAIN TERMS, TO NOT USE THEM UNTIL THE BURNS WERE TOTALLY HEALED. DOSE OR AMOUNT: 1 PATCH, FREQUENCY: NO MORE THAN 4 DAILY, ROUTE: TOP. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: BURSITIS/MUSCLE ACHES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT PATCH MENTHOL 5% NONE IMD CHATTEM F037

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other