BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENGAY MOIST HEAT THERAPY

    MDR report key: 1387655 · Received May 15, 2009

    Report

    Report Number
    2246407-2009-00006
    Event Type
    Injury
    Date Received
    May 15, 2009
    Date of Event
    May 7, 2009
    Report Date
    May 8, 2009
    Manufacturer
    JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES
    Product Code
    OMW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    THIS WAS A SPONTANEOUS REPORT FROM A FEMALE CONSUMER REPORTING ON HERSELF. THE CONSUMER REPORTED APPLYING ONE BENGAY MOIST HEAT THERAPY PAD (NO ACTIVE INGREDIENT) ONCE DAILY AS NEEDED BEGINNING 2009 FOR MINOR ACHES AND PAINS. AFTER APPLICATION THE FOLLOWING MONTH, THE CONSUMER'S FACE WAS SWOLLEN. SHE REPORTED THAT SHE HAS A HISTORY OF ASTHMA AND ENVIRONMENTAL AND MEDICATION ALLERGIES, AND STATED THAT SHE MAY HAVE TOUCHED HER FACE AFTER HANDLING THE PRODUCT. ON THE SAME DATE, SHE VISITED A PHYSICIAN WHO PRESCRIBED STEROIDS AND GAVE HER AN INJECTION OF BENADRYL (DIPHENDYDRAMINE). PRODUCT USE WAS DISCONTINUED THE SAME DAY. AS OF THE DATE OF HER REPORT, THE NEXT DAY, THE OUTCOME OF THE EVENT WAS NOT RESOLVED. THIS CASE IS SERIOUS (MEDICALLY SIGNIFICANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENGAY MOIST HEAT THERAPY PAD, MEDICATED, ADHESIVE, NON-ELECTRIC OMW JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES ASPT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other