BEUDAMED
    FDA Adverse Event Other Summary report: N

    BENGAY MOIST HEAT THERAPY

    MDR report key: 1420460 · Received May 22, 2009

    Report

    Report Number
    2246407-2009-00007
    Event Type
    Other
    Date Received
    May 22, 2009
    Report Date
    May 11, 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 A SPONTANEOUS REPORT FROM A MALE CONSUMER REPORTING ON HIMSELF. THE CONSUMER REPORTED APPLYING BENGAY MOIST HEAT THERAPY PAD (NO ACTIVE INGREDIENT) DOSE, FREQUENCY, DATES, AND INDICATION UNSPECIFIED). AS THE CONSUMER REMOVED THE PRODUCT FROM HIS RIGHT ANKLE (DATE UNSPECIFIED), HIS "SKIN CAME OFF WITH IT." ALSO, HE WAS IN PAIN AND DISCOMFORT AND COULD HARDLY WALK OR WEAR HIS SHOES. ON AN UNSPECIFIED DATE, HE VISITED A HOSPITAL AND WAS ADVISED TO APPLY AN ANTIBIOTIC CREAM AND KEEP THE AREA COVERED AS TREATMENT. HE THOUGHT THAT THE PRODUCT'S BATCH "MUST BE 300% STRONGER". ON AN UNSPECIFIED DATE, PRODUCT USE WAS DISCONTINUED. AS OF (B) (6) 2009, THE OUTCOME OF THE EVENTS WAS NOT RESOLVED. THIS CASE IS SERIOUS (MEDICALLY SIGNIFICANT, REQUIRED INTERVENTION).

    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 A8P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R