BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM RED-COTE

    MDR report key: 5077501 · Received July 22, 2015

    Report

    Report Number
    MW5056129
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 22, 2015
    Product Code
    NYH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY ALMOST (B)(6) DAUGHTER ATE PART OF A GUM RED-COTE TABLET AND HAD AN ADVERSE ANAPHYLACTIC REACTION. SHE HAD SWELLING OF HER LIPS AND TONGUE, HIVES, AND AN ASTHMA ATTACK. WE TREATED HER WITH BENADRYL AND ALBUTEROL SULFATE VIA NEBULIZER AND THEY BROUGHT HER SYMPTOMS UNDER CONTROL. DATES OF USE: 1 USE. DIAGNOSIS OR REASON FOR USE: TOOTH BRUSHING AID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478127 GUM RED-COTE GUM RED-COTE NYH

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Life Threatening