BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1002921 · Received February 8, 2008

    Report

    Report Number
    1022556-2008-00030
    Event Type
    Other
    Date Received
    February 8, 2008
    Date of Event
    January 11, 2008
    Report Date
    January 15, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS USED OFF-LABEL. THE USER IS A TWELVE YEAR OLD AND USED THE PRODUCT WITHOUT SUPERVISION (HE HAD CALLED HIS MOTHER AT WORK WHO GAVE HIM PERMISSION TO USE THE PRODUCT). THE PRODUCT WAS ALSO USED WHILE SLEEPING AND NOT CHECKED FREQUENTLY FOR SIGNS OF IRRITATION. SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVAL AND ANALYSIS. REVIEW CONDUCTED BY MFR YIELDED NO ADDITIONAL COMPLAINTS OR TRENDS TO DATE FOR THIS LOT NUMBER. WE WILL CONTINUE TO MONITOR FOR OTHER SIMILAR COMPLAINTS, COMPOSE TREND REPORTS AND UTILIZE THE INFO FOR CONTINUOUS IMPROVEMENT. 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 PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    THE CONSUMER IS REPORTING THAT HER TWELVE YEAR OLD SON USED THE PRODUCT TO TREAT A MUSCLE STRAIN. THE PRODUCT WAS USED ON THE LEFT THIGH FOR EIGHT HOURS. UPON REMOVAL OF THE PATCH, HIS SKIN WAS RED AND BLISTERING IN THE AREA OF THE SIZE OF A QUARTER. THE MOTHER, WHO IS PEDIATRIC DR, DIAGNOSED A SECOND DEGREE BURN AND INITIALLY TREATED THE AREA WITH CORTIZONE AND A BANDAGE. SHE ALSO HAS HIM ON ANTIBIOTICS TO PREVENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 2A7QD

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR