BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVIDENT 5% SODIUM FLUORIDE VARNISH

    MDR report key: 13448969 · Received February 4, 2022

    Report

    Report Number
    0002221095-2022-00003
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    January 21, 2022
    Report Date
    January 14, 2022
    Manufacturer
    COLGATE-PALMOLIVE COMPANY GLOBAL TECHNOLOGY CENTER
    Product Code
    LBH
    PMA / PMN Number
    K103461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS IS A SPONTANEOUS REPORT RECEIVED FROM A DENTIST ON (B)(6) 2022 REGARDING TWO PATIENTS (AGE AND GENDER UNKNOWN) WHO EXPERIENCED AN ADVERSE REACTION TO PREVIDENT 5% SODIUM FLUORIDE VARNISH. THERE WAS NO RELEVANT MEDICAL HISTORY PROVIDED. ON AN UNSPECIFIED DATE, PREVIDENT 5% SODIUM FLUORIDE VARNISH WAS APPLIED AT AN UNSPECIFIED DOSE AND FREQUENCY. DENTIST REPORTED THE "PATIENTS (PEDS)" HAD AN UNSPECIFIED ADVERSE REACTION AFTER USE OF PREVIDENT 5% SODIUM FLUORIDE VARNISH. IT WAS REPORTED UNSPECIFIED MEDICAL ATTENTION WAS SOUGHT. ACTION TAKEN WITH PREVIDENT 5% SODIUM FLUORIDE VARNISH WAS UNKNOWN. AT THE TIME OF THIS REPORT OUTCOME OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM A DENTIST REGARDING A MALE CHILD (AGE REPORTED AS (B)(6)) ON 21JAN2022 AND THE CASE WAS UPGRADED TO SERIOUS. PATIENT WEIGHT WAS PROVIDED AS (B)(6) LBS. IT WAS REPORTED THE CHILD HAD NO RELEVANT MEDICAL HISTORY. ON (B)(6) 2022, PREVIDENT 5% SODIUM FLUORIDE VARNISH GRAPE FLAVOR (LOT# 11740 BL2MK) WAS APPLIED ON THE TOP AND BOTTOM OF THE TEETH (AMOUNT UNKNOWN). PATIENT EXPERIENCED SWELLING OF THE LIPS AFTER APPLICATION. EMT WAS CALLED AND THE CHILD WAS TAKEN TO EMERGENCY. IT WAS REPORTED THE CHILD RECEIVED AN UNSPECIFIED ANESTHESIA VIA IV ON (B)(6) 2022 AND WAS OBSERVED OVERNIGHT THEN RELEASED. ACTION TAKEN WITH PREVIDENT 5% SODIUM FLUORIDE VARNISH WAS DISCONTINUED ON (B)(6) 2022. AT THE TIME OF THIS REPORT, CHILD HAD RECOVERED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452381 PREVIDENT 5% SODIUM FLUORIDE VARNISH PREVIDENT 5% SODIUM FLUORIDE VARNISH LBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| H