BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT DENTURE CLEANSER

    MDR report key: 3772234 · Received April 2, 2014

    Report

    Report Number
    1020379-2014-00003
    Event Type
    Other
    Date Received
    April 2, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR REPORT NUMBER FOR THIS CASE IS 1020379-2014-00003. POLIDENT DENTURE CLEANSER IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS 5T12163. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF LIVER ABSCESS IN A MALE PT OF UNSPECIFIED AGE WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTURE CLEANSER) FOR DENTAL CARE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED SURGERY. IN (B)(6) 2013 THE PATIENT STARTED DOUBLE SALT DENTURE CLEANSER (DENTAL) DAILY. APPROX 3 MONTHS LATER, IN (B)(6) 2014, THE PT EXPERIENCED LIVER ABSCESS. THE PT RECEIVED TREATMENT WITH SURGERY AND ANTIBIOTICS. THE PT WANTED TO KNOW IF ANY INGREDIENT IN DOUBLE SALT DENTURE CLEANSER COULD MAKE LIVER FUNCTION WORSE, AS ALTHOUGH HE CLEANED HIS DENTURES WITH WATER EACH TIME AFTER USING THE CLEANSER, HE COULD TAKE IN A VERY SMALL AMOUNT OF DOUBLE SALT DENTURE CLEANSER (ACCIDENTAL INGESTION OF PRODUCT). THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH DOUBLE SALT DENTURE CLEANSER WAS CONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200058 POLIDENT DENTURE CLEANSER DOUBLE SALT DENTURE CLEANSER EFT GLAXOSMITHKLINE NA 5T12163

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other UNSPECIFIED