BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT THERAPY PATCH

    MDR report key: 857923 · Received May 30, 2007

    Report

    Report Number
    1022556-2007-00123
    Event Type
    Other
    Date Received
    May 30, 2007
    Date of Event
    April 2, 2007
    Report Date
    May 11, 2007
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER WORE FOR 3 HRS ON LOWER BACK AND ON REMOVAL NOTED REDNESS, TENDERNESS AND BLISTERS. SAW DR WHO INSTRUCTED HER TO USE NEOSPORIN ON AREA. AFTER 2 WEEKS, SAW FAMILY DR WHO DIAGNOSED SECOND DEGREE BURN WITH SOME INFECTION. SHE WAS GIVEN ANTIBIOTICS AND TOPICAL CREAM AND ADVISED TO RETURN IN WEEK IF THERE WAS NO IMPROVEMENT. MEDICAL INFO AND RECORDS HAVE BEEN REQUESTED BUT NOT REC'D.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR