BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1014170 · Received March 13, 2008

    Report

    Report Number
    1022556-2008-00260
    Event Type
    Other
    Date Received
    March 13, 2008
    Report Date
    August 30, 2007
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1196-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PACKAGE LABELING INDICATES THAT CONSUMERS SHOULD CONSULT WITH THEIR DOCTOR BEFORE USING IF THEY HAVE DIABETES. 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 IS BEING DETERMINED THAT THE PT EXPERIENCED TEMPORARY OR MEDICALLY REVERSIBLE HEALTH CONSEQUENCES. ACCORDINGLY, THIS MDR IS BEING SUBMITTED AS A VOLUNTARY AND PROACTIVE MEASURE BY THE MFR TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGLIANCE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED, USING THE PRODUCT FOR AN UNSPECIFIED AMOUNT OF TIME ON HER LEFT HIP. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED REDNESS AND SKIN REMOVAL IN FOUR SPOTS. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE INCIDENT AND TREATED THE AREA WITH TRIPLE ANTIBIOTIC OINTMENT AND BANDAIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 3A6ZK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INSULIN| NASONEX