BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTU CREME

    MDR report key: 8469168 · Received April 1, 2019

    Report

    Report Number
    1314819-2019-00002
    Event Type
    Injury
    Date Received
    April 1, 2019
    Report Date
    March 18, 2019
    Manufacturer
    GSK EAST DURHAM
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    I MIGHT HAVE SWALLOWED SOME [ACCIDENTAL DEVICE INGESTION], CAUSE BREATHING ISSUES AND ALL THIS IS THAT TRUE [DIFFICULTY BREATHING], I BRUSHED MY TEETH WITH THIS [DEVICE USE ISSUE], THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6) FEMALE PATIENT WHO RECEIVED DENTURE CLEANSER (POLIDENT DENTU CREME) TOOTHPASTE (BATCH NUMBER ILIT258H, EXPIRY DATE 31ST MARCH 2020) FOR DENTAL CLEANING. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT DENTU CREME. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTU CREME, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), DIFFICULTY BREATHING AND DEVICE USE ISSUE. THE ACTION TAKEN WITH POLIDENT DENTU CREME WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, DIFFICULTY BREATHING AND DEVICE USE ISSUE WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION AND DEVICE USE ISSUE TO BE RELATED TO POLIDENT DENTU CREME. THE REPORTER CONSIDERED THE DIFFICULTY BREATHING TO BE RELATED TO POLIDENT DENTU CREME. ADDITIONAL DETAILS: THE ADVERSE EVENT INFORMATION WAS RECEIVED VIA PHONE CALL ON (B)(6) 2019. THE CONSUMER REPORTED THAT, "I AM CALLING IN ABOUT POLIDENT CREME, I BRUSHED MY TEETH WITH THIS, I DID NOT MEAN TOO. I LOOKED IT UP ONLINE, IT COULD CAUSE BREATHING ISSUES AND ALL THIS, IS THAT TRUE? I MIGHT HAVE SWALLOWED SOME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264257 POLIDENT DENTU CREME DENTURE CLEANSER EFT GSK EAST DURHAM ILIT258H

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other