BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1021502 · Received March 27, 2008

    Report

    Report Number
    1022556-2008-00425
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    September 23, 2007
    Report Date
    March 4, 2008
    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

    THE CONSUMER MOST LIKELY USED THE PROD OFF-LABEL BY PUTTING PRESSURE ON THE PATCH FOR AN EXTENDED PERIOD OF TIME (THE CONSUMER WORE THE PROD ON HIS LOWER BACK FOR THREE HRS WHILE DRIVING). SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVAL AND ANALYSIS. THE LOT # WAS NOT PROVIDED FROM THE RPTR TO CONDUCT TREND 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 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 THREE HRS ON HIS LOWER BACK. WHEN THE PATCH WAS REMOVED, THE CONSUMER CLAIMED TO HAVE REC'D A SELF-DESCRIBED SECOND DEGREE BURN WITH BLISTERING, SKIN REMOVAL AND SCARRING. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE INCIDENT AND SELF TREATED THE AREA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR THE CUSUMER REPORTED TAKING ZIAC AT THE TIME OF| OF THE INCIDENT.