BEUDAMED
    FDA Adverse Event Summary report: N

    BENGAY MOIST HEAT THERAPY

    MDR report key: 1062406 · Received June 13, 2008

    Report

    Report Number
    2246407-2008-00005
    Date Received
    June 13, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 15, 2008
    Manufacturer
    JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR FAILURE ANALYSIS/LABORATORY TESTING. IT CANNOT BE RULED OUT THAT THE PRODUCT MAY HAVE POSSIBLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A (B) (6) FEMALE CONSUMER APPLIED 1 BENGAY MOIST HEAT THERAPY (NO ACTIVE INGREDIENT). ON (B) (6) 2008 (INDICATION UNSPECIFIED) AND HAD NO PROBLEMS. SHE APPLIED THE PATCH AGAIN ON (B) (6) 2008, AND DID NOT LEAVE IT ON FOR 8 HOURS. AFTER SHE REMOVED THE PATCH ON (B) (6) 2008, SHE HAD A SECOND DEGREE BURN WITH SLIGHT ITCHINESS AND WHITE AND RED BLISTERS. SHE SAW A PHYSICAL THERAPIST (DATE UNSPECIFIED) AND WAS ADVISED NOT TO TOUCH OR TRY TO TREAT THE EFFECTED AREA. PRODUCT USE WAS DISCONTINUED ON (B) (6) 2008. AS OF (B) (6) 2008, THE OUTCOME OF THE EVENTS WAS REPORTED AS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENGAY MOIST HEAT THERAPY NONE IMD JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other