BEUDAMED
    FDA Adverse Event Other Summary report: N

    J&J TARTAR CONTROL DENTAL

    MDR report key: 556212 · Received November 18, 2004

    Report

    Report Number
    1046432-2004-00002
    Event Type
    Other
    Date Received
    November 18, 2004
    Date of Event
    November 13, 2004
    Report Date
    November 16, 2004
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS, INC.
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED THEY EXPERIENCED SWELLING AND TINGLING IN MOUTH AND THROAT. WENT TO EM RM 11/2004 8:43:02AM MED. SERVICE RECEIVED A CALL FROM CONS STATING THAT DURING USE OF THE FLOSS, THEIR THROAT AND MOUTH BEGAN TO TINGLE AND SWELL. PT STATED THAT THEY FELT AS IF THEIR "THROAT WAS CLOSING". PT DENIES ANY DIFFICULTY BREATHING. PT STATED THAT WITHIN THE LAST MONTH THEY BEGAN TO HAVE REACTION TO SEAFOOD, PEANUTS, AND POSSIBLY OTHER FLAVORINGS. PT HAD SELF ADMINISTERED TWO INJECTIONS OF EPINEPHRINE IN THE FORM OF AN EPI PEN. PT STATED THAT THEIR SYMPTOMS DID NOT LESSEN. PT WENT TO THE EMERGENCY ROOM AND WAS GIVEN ANOTHER ROUND OF STEROIDS. PT STATED THAT WAS KEPT FOR "SEVERAL HOURS" IN THE E.R. PT STATED THAT TWO DAYS PRIOR TO REACTION TO FLOSS,THEY HAD AN EPISODE AFTER THE USE OF A PRODUCT THAT CONTAINED A FLAVORING IN THE ANISE FAMILY. PT IS UNAWARE IF REACTION IS CONNECTED. PT HAS SCHEDULED A FOLLOW UP APPOINTMENT WITH THEIR ALLERGIST LAST IN THE WEEK. ADVISED PT TO D/C FUTURE USE OF THE PRODUCT. MED. SERVICE DISCUSSED INDIVIDUAL SENSITIVITIES. ADVISED PT THAT PRIORITY QUALITY MAILER WAS BEING SENT. REFERENCE NUMBER GIVEN, REFUND ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J&J TARTAR CONTROL DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. NA 2114D

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention