BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1021124 · Received March 27, 2008

    Report

    Report Number
    1022556-2008-00429
    Event Type
    Other
    Date Received
    March 27, 2008
    Report Date
    March 5, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1198-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE CONSUMER'S CHRONIC PAIN IS MOST LIKELY UNRELATED TO THE USE OF THE PROD AND RELATED TO THE ORIGINAL UNDERLYING MEDICAL CONDITION SHE WAS TRYING TO TREAT WITH THE PATCH. ADDITIONALLY, WE ARE UNAWARE OF ANY SIMILAR CASES WHERE THE USED OF THIS PROD CAUSED INTERNAL INJURY OR RESULTED IN CHRONIC JOINT PAIN. 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

    A STORE REP REPORTED A CONSUMER USED THE PROD FOR AN UNSPECIFIED AMOUNT OF TIME ON HER KNEE. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED A RED SHINY SPOT IN THE AREA WORN. SINCE THE INCIDENT THE CONSUMER HAS EXPERIENCED CHRONIC KNEE PAIN. THE CONSUMER HAS CONSULTED WITH HER DR AND A SPECIALIST WHO PERFORMED X-RAYS AND MRI'S, BUT COULD NOT FIND THE ROOT OF THE PROBLEM.

    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 UNK