BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVIDENT 5% SODIUM FLUORIDE VARNISH

    MDR report key: 13449013 · Received February 4, 2022

    Report

    Report Number
    0002221095-2022-00004
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    January 12, 2022
    Report Date
    January 21, 2022
    Manufacturer
    COLGATE-PALMOLIVE COMPANY GLOBAL TECHNOLOGY CENTER
    Product Code
    LHW
    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 21JAN2022 REGARDING A (B)(6) YEARS OLD FEMALE PATIENT WHO EXPERIENCED ANGIOEDEMA FOLLOWING APPLICATION OF PREVIDENT 5% SODIUM FLUORIDE VARNISH. THERE WAS NO RELEVANT MEDICAL HISTORY PROVIDED. ON (B)(6) 2022, 1 SWAB OF PREVIDENT 5% SODIUM FLUORIDE VARNISH GRAPE FLAVOR (LOT# 11740 BL2MK) WAS APPLIED. DENTIST REPORTED THAT AFTER APPLYING THE PRODUCT, THE CHILD EXPERIENCED "SIGNIFICANT ANGIOEDEMA OF THE LIPS" WITH NO OTHER SWELLING OF ORAL TISSUES. AFTER 15 MINUTES OF MONITORING THERE WAS NO DECREASE IN SWELLING AND THE CHILD WAS SENT TO ER. THE CHILD RECEIVED AN UNSPECIFIED ANESTHESIA VIA IV ON (B)(6) 2022 AND WAS KEPT IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. ON (B)(6) 2022, THE SWELLING HAD SUBSIDED AND THE CHILD WAS RELEASED FROM THE HOSPITAL. PREVIDENT 5% SODIUM FLUORIDE VARNISH WAS STOPPED AFTER ONE APPLICATION OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946244 PREVIDENT 5% SODIUM FLUORIDE VARNISH PREVIDENT 5% SODIUM FLUORIDE VARNISH LHW

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female Other| H