BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTU CREME TOOTHPASTE

    MDR report key: 5793554 · Received July 14, 2016

    Report

    Report Number
    1314819-2016-00001
    Event Type
    Injury
    Date Received
    July 14, 2016
    Date of Event
    July 5, 2016
    Report Date
    July 5, 2016
    Manufacturer
    GLAXOSMITHKLINE LLC
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCIDENTAL INGESTION OF PRODUCT [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER ((B)(6) DENTU CREME TOOTHPASTE) TOOTHPASTE (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON (B)(6) 2016, THE PATIENT STARTED (B)(6) DENTU CREME TOOTHPASTE. ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING (B)(6) DENTU CREME TOOTHPASTE, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO (B)(6) DENTU CREME TOOTHPASTE. ADVERSE EVENT (AE) INFORMATION WAS REPORTED BY CONSUMER ON 05 JULY 2016. THE CONSUMER REPORTED THAT SHE ACCIDENTALLY INGESTED THE PRODUCT. (B)(6) DENTU CREME TOOTHPASTE WAS CONTINUED WITH NO CHANGE. FOLLOW UP WAS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447641 POLIDENT DENTU CREME TOOTHPASTE DENTURE CLEANSER EFT GLAXOSMITHKLINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other