BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTU CREME

    MDR report key: 5960769 · Received September 19, 2016

    Report

    Report Number
    1314819-2016-00007
    Event Type
    Injury
    Date Received
    September 19, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 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

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), POLIDENT DENTU CRÈME.

    Description of Event or Problem · 1

    DOES BELIEVE THAT SHE SWALLOWED SOME OF PRODUCT [ACCIDENTAL DEVICE INGESTION]. 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 DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTU CREME) CREAM (BATCH NUMBER (B)(4), EXPIRY DATE 30TH SEPTEMBER 2018) FOR DENTAL CLEANING. ON (B)(6) 2016, THE PATIENT STARTED POLIDENT DENTU CREME. ON (B)(6) 2016, LESS THAN A DAY AFTER STARTING POLIDENT DENTU CREME, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL INGESTION OF DRUG. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION AND ACCIDENTAL INGESTION OF DRUG WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO POLIDENT DENTU CREME. ADDITIONAL DETAILS, THIS ADVERSE EVENT INFORMATION RECEIVED ON (B)(6) 2016. CONSUMER REPORTED THAT SHE BRUSHED HER TEETH TODAY ((B)(6) 2016) WITH THE POLIDENT DENTU CREME 3.9 OZ BY MISTAKE AND IMMEDIATELY SPIT IT OUT. SHE USED THE POLIDENT BY MISTAKE DUE TO THE FACT THAT IT WAS SITTING NEAR HER TOOTHPASTE ON THE SINK. SHE DID RINSE HER MOUTH AND DID BELIEVE THAT SHE SWALLOWED SOME OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612709 POLIDENT DENTU CREME DENTURE CLEANSER EFT GLAXOSMITHKLINE LLC 5L28CH

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other