BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1604244 · Received February 9, 2010

    Report

    Report Number
    1022556-2010-00008
    Event Type
    Other
    Date Received
    February 9, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 23, 2010
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1197-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PRODUCT 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

    CONSUMER REPORTED THAT SHE APPLIED PRODUCT TO LEFT HIP AND WORE FOR 6 HOURS. UPON REMOVAL OF PRODUCT, SKIN WAS REMOVED - "3 AREAS THE SIZE OF DIMES AND SEVERAL OTHER SPOTS". AREAS WERE TREATED WITH NEOSPORIN. (B)(4).

    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 63 YR Other CELEBREX| BLOOD PRESSURE MEDICINE,| DARVOCET