BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 989961 · Received January 31, 2008

    Report

    Report Number
    1022556-2008-00009
    Event Type
    Other
    Date Received
    January 31, 2008
    Date of Event
    December 26, 2007
    Report Date
    January 3, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CONSUMER'S REPORT OF THE INCIDENT, THE EXACT CAUSE OF THE ANAPHYLACTIC REACTION IS UNCLEAR. THE TIMING AND PRESENTATION OF THE ANAPHYLACTIC REACTION, SUGGESTS THAT THE REACTION MAY NOT BE DIRECTLY CAUSED BY THE PATCH. LISINOPRIL (AS WELL AS OTHER ACE INHIBITORS) HAVE BEEN ASSOCIATED WITH ANAPHYLACTIC REACTIONS RESULTING IN ANGIOEDEMA WHICH CAN OCCUR AT ANY TIME DURING TREATMENT. THIS ANGIOEDEMA MAY INVOLVE HEAD AND NECK WHICH COULD POTENTIALLY AFFECT THE AIRWAY. THE PRODUCT AND LOT NUMBER WAS NOT PROVIDED FROM THE REPORTER. THEREFORE, WE ARE UNABLE TO PROCEED WITH DEVICE EVALUATION OR 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 PRODUCT 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 MANUFACTURER TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED USING THIS PRODUCT OR RELATED PRODUCT AT SOME UNSPECIFIED TIME IN THE PAST WITHOUT MENTIONING ANY ADVERSE EVENT. PRESENT USE, HOWEVER, RESULTED IN SOME REDNESS ON NECK AND FINGERS. THE CONSUMER DIDN'T THINK THE REDNESS WAS RELATED TO THE PATCH AT THE TIME. THE NEXT TIME THE CONSUMER USED A PATCH (FROM A DIFFERENT BOX) HE WORE IT FOR 7 HRS TO TREAT TENDONITIS. AFTER REMOVING THE SECOND PATCH, THE CONSUMER NOTICED SOME SMALL BUMPS ON NECK WHERE THE PATCH WAS APPLIED. THE NEXT DAY, SWELLING HAD GROWN AND HE WENT TO THE EMERGENCY ROOM. HE WAS GIVEN CORTISONE, BENADRYL AND PREDNISONE. THE CONSUMER RETURNED TO THE ER THE FOLLOWING DAY BECAUSE HIS THROAT HAD SWELLED SHUT AND HE HAD WELTS ALL OVER HIS BODY. HE WAS TOLD IT WAS ANAPHYLACTIC SHOCK AND WAS GIVEN SHOTS OF EPHEDRINE AND ADRENALINE. THE CONSUMER MADE AN APPOINTMENT WITH AN ALLERGY SPECIALIST. THE CONSUMER ALSO REPORTED THAT HE HAD A KETONE REACTION TO GLUE 12 YRS PREVIOUSLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR LISINOPRIL UP UNTIL TIME OF INCIDENT.| THE CONSUMER WAS TAKING THE BLOOD PRESSURE MED