BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1021138 · Received March 27, 2008

    Report

    Report Number
    1022556-2008-00405
    Event Type
    Other
    Date Received
    March 27, 2008
    Report Date
    March 3, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1196-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. 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 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 HRS ON HER LEFT SHOULDER. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED A BURN WHICH CAUSED A SCAR. THE CONSUMER CONSULTED WITH HER PRIMARY CARE PHYSICIAN REGARDING THE INJURY AND WAS PRESCRIBED AN UNSPECIFIED BURN CREAM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 THE CONSUMER REPORTED TAKING AN ORAL CONTRACEPTIVE| AT THE TIME OF THE INCIDENT.