BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1021135 · Received March 27, 2008

    Report

    Report Number
    1022556-2008-00416
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 4, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1197-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER USED THE PROD OFF-LABEL BY WEARING THE PATCH WHILE SLEEPING. FURTHERMORE, PACKAGE LABELING INDICATES THAT CONSUMERS SHOULD CONSULT WITH THEIR DR IF THEY HAVE DIABETES. 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 PROD 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 FOUR AND A HALF HRS ON HIS RIGHT SHOULDER WHILE SLEEPING. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED A BURN WITH BLISTERING AND SKIN REMOVAL IN THE AREA WORN. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE INCIDENT AND TREATED THE AREA WITH BURN OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 2A7QC

    Patients

    Seq Age Sex Outcome Treatment
    1 THE CONSUMER REPORTED TAKING UNSPECIFIED| MEDICATIONS FOR DIABETES| CHOLESTEROL AT THE TIME OF THE INCIDENT.