BEUDAMED
    FDA Adverse Event Other Summary report: N

    BENGAY MOIST HEAT THERAPY

    MDR report key: 1583374 · Received January 20, 2010

    Report

    Report Number
    2246407-2010-00001
    Event Type
    Other
    Date Received
    January 20, 2010
    Date of Event
    December 29, 2009
    Report Date
    January 12, 2010
    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

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED FOR FAILURE ANALYSIS/LABORATORY TESTING. GIVEN THE CIRCUMSTANCES OF THE REPORTED EVENT(S) AND THE KNOWN MECHANISM OF ACTION OF THE DEVICE, A CAUSAL ASSOCIATION WITH THE DEVICE IS POSSIBLE.

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS REPORT FROM A FEMALE CONSUMER REPORTING ON HERSELF(AGE UNSPECIFIED). THE CONSUMER APPLIED ONE BENGAY MOIST HEAT THERAPY PATCH (NO ACTIVE INGREDIENT) ON (B)(6) 2009 (FREQUENCY OF USE AND INDICATION UNSPECIFIED). THE CONSUMER STATED THAT PRODUCT DID NOT STICK ON APPLICATION SITE. AFTER TAKING PATCH OFF (DATE UNSPECIFIED); IT TORE HER SKIN OFF DEEP AND AFTER PRODUCT USE, SHE COULD NOT LIE OR SIT ON THAT SIDE. ON AN UNSPECIFIED DATE, CONSUMER CONSULTED WITH HER PHYSICIAN WHO PRESCRIBED UNSPECIFIED MEDICATION AS TREATMENT. CONSUMER ALSO USED HYDROGEL (NON-COMPANY DRUG) WITH DRESSING AS TREATMENT. AS OF (B)(6) 2010, BOTH PRODUCT USE AND THE OUTCOME OF THE EVENT WERE UNK. 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 A807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R