BEUDAMED
    FDA Adverse Event Summary report: N

    BENGAY MOIST HEAT THERAPY

    MDR report key: 1406539 · Received June 19, 2009

    Report

    Report Number
    2246407-2009-00009
    Date Received
    June 19, 2009
    Date of Event
    June 5, 2009
    Report Date
    June 10, 2009
    Manufacturer
    JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES
    Product Code
    OMW
    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

    THIS WAS AN SPONTANEOUS REPORT FROM A (B)(6), FEMALE, CONSUMER, REPORTING ON HERSELF. THE CONSUMER REPORTED USING ONE PAD OF BENGAY MOIST HEAT THERAPY (NO ACTIVE INGREDIENT) 7 TO 8 HOURS BEGINNING ON (B)(6) 2009 FOR PAIN IN SHOULDER. ON (B)(6) 2009, CONSUMER REPORTED A CHEMICAL BURN ON HER SHOULDER. SHE ALSO MENTIONED THAT WHEN SHE REMOVED THE PRODUCT FROM APPLICATION SITE, IT TOOK HER SKIN OFF AND HAD BLEEDING. AS TREATMENT, CONSUMER USED ANTIBIOTIC OINTMENT AND A BAND AID. PRODUCT WAS DISCONTINUED ON (B)(6) 2009 AND THE OUTCOME OF THE EVENTS WAS REPORTED AS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other