BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENGAY MOIST HEAT THERAPY

    MDR report key: 1257428 · Received December 4, 2008

    Report

    Report Number
    2246407-2008-00011
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    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 A SPONTANEOUS REPORT RECEIVED FROM A MALE CONSUMER REPORTING ON HIMSELF. THE CONSUMER REPORTED USING ONE BENGAY MOIST HEAT THERAPY PATCH (NO ACTIVE INGREDIENT) ONCE ON (B) (6) 2008, TO TREAT MUSCLE PAIN. AFTER PRODUCT USE (DATE UNSPECIFIED), HIS SKIN BURNED. AS OF (B) (6) 2008, THE OUTCOME OF THE EVENT WAS UNK. THE CASE IS SERIOUS (MEDICALLY SIGNIFICANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENGAY MOIST HEAT THERAPY DEVICE DELIVERY AID OMW JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES A7XJ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other