BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 948518 · Received November 6, 2007

    Report

    Report Number
    1022556-2007-00289
    Event Type
    Other
    Date Received
    November 6, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 10, 2007
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED LETTER FROM STORE CLAIMS MANAGEMENT ON BEHALF OF CONSUMER. "CUSTOMER ALLEGES, HE SLEPT OVERNIGHT ON HEATING PAD AND WHEN HE PULLED IT OFF THE NEXT MORNING, IT RIPPED HIS SKIN OFF." CONSUMER WAS CONTACTED ON 10/16/2007 FOR FOLLOW-UP INFO. HE HAD BEEN HAVING SOME BACK PROBLEMS, SO HE WORE PRODUCT FOR THE FIRST TIME FOR 5-6 HOURS. WHEN REMOVING, HE FELT NEEDLES ON HIS BACK & THE PATCH HAD HIS SKIN ON IT. CONSUMER DID NOT PROVIDE ANY TREATMENT INFO AND HAS NOT SEEN A HEALTH PROFESSIONAL.

    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 YR