BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1014225 · Received March 13, 2008

    Report

    Report Number
    1022556-2008-00206
    Event Type
    Other
    Date Received
    March 13, 2008
    Date of Event
    December 1, 2007
    Report Date
    February 13, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1196-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PACKAGING LABELING INDICATES THAT CONSUMERS SHOULD CONSULT WITH THEIR DOCTOR IF THEY HAVE DIABETES. THE CONSUMER USED THE PRODUCT OFF-LABEL BY WEARING IT WHILE SLEEPING. SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVALUATION 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 PATIENT EXPERIENCED TEMPORARY OR MEDICALLY REVERSIBLE ADVERSE HEALTH CONSEQUENCES. ACCORDINGLY, THIS MDR IS BEING SUBMITTED AS A VOLUNTARY AND PROACTIVE MEASURE BY THE MANUFACTURER TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED, HER HUSBAND USED THE PRODUCT OVERNIGHT ON HIS BACK. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED BLISTERING IN THE AREA WORN. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE INCIDENT AND TREATED THE AREA WITH BANDAIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 3A6Z8

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDICATIONS FOR HIGH BLOOD PRESSURE| THE CONSUMER REPORTED TAKING UNSPECIFIED| DIABETES AND HIGH CHOLESTEROL