BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOBY GROWLIN GRAPE

    MDR report key: 16362683 · Received February 13, 2023

    Report

    Report Number
    1941138-2023-00001
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    November 23, 2022
    Report Date
    January 31, 2023
    Manufacturer
    YOUNG DENTAL MANUFACTURING 1, LLC
    Product Code
    EJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS THE FIRST TIME THE PATIENT WAS AT THE DENTIST FOR A TEETH CLEANING. THE DENTIST HAD JUST STARTED THE CLEANING ON ONE TOOTH BEFORE THE REACTION, HAD ONLY USED THE ZOOBY GROWLIN GRAPE PROPHY PASTE - PART NUMBER, LOT NUMBER, GRIT LEVEL ARE UNKNOWN SO UDI IS NOT KNOWN. DENTIST WAS WEARING GLOVES BUT THE CHILD HAS NEVER HAD ANY REACTIONS TO LATEX BEFORE - CHILD HAS COME IN CONTACT WITH LATEX BALLOONS IN THE PAST WITH NO PROBLEM. THE PATIENT VOMITED IMMEDIATELY, DEVELOPED HIVES AND HAD ISSUES BREATHING. AN EPIPEN WAS ADMINISTERED AT THE DENTAL OFFICE AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AT (B)(6) HOSPITAL. IT IS NOT KNOWN IF ANY TREATMENT WAS RECEIVED AT THE EMERGENCY ROOM. PENICILLIN IS THE ONLY KNOWN ALLERGY OF THE PATIENT. MOTHER PLANS TO HAVE AN ALLERGY TEST PERFORMED ON CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648050 ZOOBY GROWLIN GRAPE PROPHY PASTE EJR YOUNG DENTAL MANUFACTURING 1, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Required Intervention| O