BEUDAMED
    FDA Adverse Event Other Summary report: N

    JOHNSON & JOHNSON REACH GENTLE GUM CARE, FRESH MINT

    MDR report key: 533001 · Received March 10, 2004

    Report

    Report Number
    1046432-2004-00001
    Event Type
    Other
    Date Received
    March 10, 2004
    Date of Event
    February 28, 2004
    Report Date
    March 4, 2004
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS, INC.
    Product Code
    JES
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CONSUMER GOT A PIECE OF FLOSS STUCK BETWEEN THEIR TEETH. THEY USED ANOTHER PIECE OF FLOSS TO REMOVE IT BUT THEIR MOUTH BEGAN TO FEEL SWOLLEN. LIPS BECAME SWOLLEN, HANDS AND GENITALS BEGAN TO FEEL ITCHY, HAD DIFFICULTY SWALLOWING. THEY CALLED A PHYSICIAN FRIEND WHO RECOMMENDED BENADRYL. THEY DISSOLVED BENADRYL IN WATER AS THEY COULDN'T SWALLOW THE PILLS AND SYMPTOMS DIMINISHED. CONSUMER WAS TAKING PREDNISONE ON A TAPER REGIMEN WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON & JOHNSON REACH GENTLE GUM CARE, FRESH MINT DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. * 1770D

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other PREDNISONE.