BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTU CREME TOOTHPASTE

    MDR report key: 5796679 · Received July 14, 2016

    Report

    Report Number
    1314819-2016-00002
    Event Type
    Injury
    Date Received
    July 14, 2016
    Report Date
    July 8, 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

    REPORT # 1314819-2016-00002 IS ASSOCIATED WITH (B)(4) POLIDENT DENTU CREME TOOTHPASTE.

    Description of Event or Problem · 1

    SWALLOWED SOME OF THE PRODUCT [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A MALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTU CREME TOOTHPASTE) TOOTHPASTE (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DENTAL CLEANING. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT DENTU CREME TOOTHPASTE. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT 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 POLIDENT DENTU CREME TOOTHPASTE. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON 08 JULY 2016. THE CONSUMER REPORTED THAT HE SWALLOWED SOME OF THE PRODUCT AND ASKED IF IT WAS TOXIC. HE WOULD RINSE HIS MOUTH AND DRANK WATER. HE WOULD THEN SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450288 POLIDENT DENTU CREME TOOTHPASTE DENTURE CLEANSER EFT GLAXOSMITHKLINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other