BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTU CREME

    MDR report key: 7723803 · Received July 26, 2018

    Report

    Report Number
    1314819-2018-00001
    Event Type
    Injury
    Date Received
    July 26, 2018
    Report Date
    July 11, 2018
    Manufacturer
    GSK EAST DURHAM
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1314819-2018-00001 IS ASSOCIATED WITH ARGUS CASE (B)(4), POLIDENT DENTU CRÈME.

    Description of Event or Problem · 1

    I MAY HAVE SWALLOWED A SMALL AMOUNT (ACCIDENTAL DEVICE INGESTION). THE PRODUCT GAVE ME UPSET STOMACH YESTERDAY (UPSET STOMACH). I THOUGHT IT WAS POLIGRIP, AND I PUT IT IN MY MOUTH (WRONG DEVICE USED). CASE DESCRIPTION: 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 7L25CH, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON (B)(6) 2018, THE PATIENT STARTED POLIDENT DENTU CREME. ON (B)(6) 2018, LESS THAN A DAY AFTER STARTING POLIDENT DENTU CREME, THE PATIENT EXPERIENCED WRONG DEVICE USED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND UPSET STOMACH. THE ACTION TAKEN WITH POLIDENT DENTU CREME WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, UPSET STOMACH AND WRONG DEVICE USED WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION AND WRONG DEVICE USED TO BE RELATED TO POLIDENT DENTU CREME. THE REPORTER CONSIDERED THE UPSET STOMACH TO BE RELATED TO POLIDENT DENTU CREME. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON 11 JULY 2018. CONSUMER REPORTED THAT, "I PUT POLIDENT DENTU-CREME ON MY DENTURE BECAUSE I THOUGHT IT WAS POLIGRIP, AND I PUT IT IN MY MOUTH. I MAY HAVE SWALLOWED A SMALL AMOUNT. WAS IT HARMFUL. THE PRODUCT GAVE ME UPSET STOMACH YESTERDAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565123 POLIDENT DENTU CREME DENTURE CLEANSER EFT GSK EAST DURHAM 7L25CH

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other