BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1002931 · Received February 8, 2008

    Report

    Report Number
    1022556-2008-00035
    Event Type
    Other
    Date Received
    February 8, 2008
    Date of Event
    January 13, 2008
    Report Date
    January 17, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVAL AND ANALYSIS. REVIEW CONDUCTED BY MFR YIELDED NO SIGNIFICANT COMPLAINTS OR TRENDS REGARDING 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 USED THE PRODUCT FOR LESS THAN ONE HOUR TO TREAT A SORE SHOULDER. THE PATCH WAS APPLIED TO THE TOP OF THE RIGHT SHOULDER, DOWN THE BACK AND CHEST AREA. THE PATCH WAS DIFFICULT TO REMOVE AND SOME SKIN REMAINED ADHERED TO THE PATCH. THE CONSUMER DESCRIBED BURNS IN THE AREA WHERE THE PATCH WAS APPLIED. SHE TREATED THE AREA WITH VITAMIN E WHICH IN BEGINNING TO HEAL. THE CONSUMER DID NOT SEEK MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 3A7SM

    Patients

    Seq Age Sex Outcome Treatment
    1 THE CONSUMER WAS ALSO TAKING| UNSPECIFIED PAINKILLERS FOR SHOULDER AT THE| TIME OF THE INCIDENT