BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1021132 · Received March 27, 2008

    Report

    Report Number
    1022556-2008-00419
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    January 5, 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
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER USED THE PROD OFF-LABEL BY WEARING THE PATCH WHILE SLEEPING. 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 ON THE INSIDE OF HER RIGHT CALF WHILE SLEEPING. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED A BURN WITH SKIN REMOVAL WHICH CAUSED A SCAR. THE CONSUMER CONSULTED WITH HER DR WHO CLEANED AND BANDAGED THE WOUND AS WELL AS ADVISED HER TO CLEAN THE AREA TWICE DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 2A7Q5

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR CHOLESTEROL MEDICATION AT THE TIME OF THE INCIDENT| THE CONSUMER REPORTED TAKING AN UNSPECIFIED