BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENGAY MOIST HEAT THERAPY

    MDR report key: 1387656 · Received May 15, 2009

    Report

    Report Number
    2246407-2009-00008
    Event Type
    Injury
    Date Received
    May 15, 2009
    Date of Event
    April 26, 2009
    Report Date
    April 27, 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 SELF-REPORT RECEIVED FROM MALE CONSUMER. THE CONSUMER USED 1 PATCH OF BENGAY MOIST HEAT THERAPY PAD (NO ACTIVE INGREDIENT) ONCE IN 2009, FOR LEG PAIN. HE LEFT IT ON ALL NIGHT AND GOT UP NEXT MORNING. THE NEXT DAY, THE PRODUCT LEFT A WELT ON HIS THIGH WERE THE PRODUCT WAS APPLIED. IT WAS ABOUT 3 INCHES IN SIZE, AND RED, UGLY, AND BURNING. THE EVENTS WERE TREATED WITH NEOSPORIN. PRODUCT USE WAS DISCONTINUED THE FOLLOWING DAY. AS 2009, THE EVENTS DID NOT RESOLVED. THIS CASE IS NON-SERIOUS (MEDICALLY SIGNIFICANT). THIS CASE HAS BEEN REASSESSED AS SERIOUS BASED UPON ADDITIONAL INFORMATION RECEIVED THE FOLLOWING MONTH. THE CONSUMER REPORTED THAT THE WELT ON HIS LEG WHICH CAUSED BY THE PRODUCT WAS NOT GOING AWAY. THIS CASE IS SERIOUS (MEDICALLY SIGNIFICANT, PERMANENT DAMAGE).

    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 87 YR Other| S