BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLIDENT DENTURE CLEANSER TABLETS

    MDR report key: 3426503 · Received October 17, 2013

    Report

    Report Number
    1020379-2013-00011
    Event Type
    Death
    Date Received
    October 17, 2013
    Date of Event
    September 3, 2013
    Report Date
    October 16, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POLIDENT TABLETS ARE MANUFACTURED IN (B)(4), IN THE UNITED STATES, AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT ARE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF LOSS OF APPETITE IN A FEMALE PT WHO RECEIVED DOUBLE SALT DENTAL CLEANSER (POLIDENT DENTURE CLEANSER TABLETS) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON (B)(6) 2013, THE PT HAD MISTAKENLY INGESTED 1 TABLET OF DOUBLE SALT DENTAL CLEANSER WHICH BELONGED TO HER DAUGHTER; ACCIDENTAL INGESTION OF DRUG. LATER, ON THE SAME DAY, ON (B)(6) 2013, THE PT EXPERIENCED LOSS OF APPETITE. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. F/U INFO RECEIVED ON (B)(4) 2013: ON (B)(6) 2013, THE PT STARTED USING DOUBLE SALT DENTAL CLEANSER. APPROX 54 DAYS LATER, ON (B)(6) 2013, THE PT EXPERIENCED HEART FAILURE. AT THE TIME OF REPORTING, THE EVENTS WERE FATAL. IT WAS REPORTED THAT THE EVENT OF LOSS OF APPETITE REMAINED UNRESOLVED TO THE PT'S DEATH. THE PT DIED ON (B)(6) 2013 FROM HEART FAILURE. IT IS UNK WHETHER AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532813 POLIDENT DENTURE CLEANSER TABLETS DOUBLE SALT DENTURE CLEANSER EFT GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death