BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1013195 · Received March 12, 2008

    Report

    Report Number
    1022556-2008-00169
    Event Type
    Other
    Date Received
    March 12, 2008
    Date of Event
    January 7, 2008
    Report Date
    February 12, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER MAY HAVE USED THE PROD OFF-LABEL BY PUTTING PRESSURE ON THE PATCH FOR AN EXTENDED PERIOD OF TIME; SHE WORE IT WHILE FLYING TO VACATION. SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVAL AND ANALYSIS. THIS REPORT IS BELOW THE THRESHOLD OF THE FDA'S REQUIREMENTS FOR MANDATORY REPORTING OF ADVERSE EVENTS INVOLVING MEDICAL DEVICES AS THERE IS NO EVIDENCE THAT USE OF THE PRODUCT RESULTED IN SERIOUS ADVERSE HEALTH CONSEQUENCES. INSTEAD, OUR INVESTIGATION HAS DETERMINED THAT THE PT EXPERIENCED TEMPORARY OR MEDICALLY REVERSIBLE ADVERSE HEALTH CONSEQUENCES. ACCORDINGLY, THIS MDR IS BEING SUBMITTED AS A VOLUNTARY AND PROACTIVE MEASURE BY THE MFR TO ENHANCE PROD SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED USING THE PROD FOR SEVEN HRS ON THE RIGHT SIDE OF HER HIP. WHEN THE PATCH WAS REMOVED, THE CONSUMER CLAIMED TO HAVE RECEIVED A BURN, SKIN REMOVAL, BLEEDING AND SCARRING IN THE AREA WORN. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE INCIDENT AND TREATED THE AREA WITH TRIPLE ANTIBIOTIC OINTMENT, BANDAGES AND BENADRYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 2A75A

    Patients

    Seq Age Sex Outcome Treatment
    1 THE CONSUMER REPORTED TAKING NEXIUM| MEDICATION.| WELL AS PRESCRIPTION BLOOD PRESSURE & CHOLESTROL