BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTURE ADHESIVE CREAM FRESH MINT

    MDR report key: 8678665 · Received June 7, 2019

    Report

    Report Number
    3003721894-2019-00140
    Event Type
    Injury
    Date Received
    June 7, 2019
    Report Date
    May 21, 2019
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    KIDNEY FUNCTION IS COMPLETELY GONE [FUNCTION KIDNEY DECREASED], UREMIA [UREMIA], BLURRY MIND [MENTAL IMPAIRMENT], I HAD BAD KIDNEY, BUT AFTER USING THE ADHESIVE CREAM, THE KIDNEY WAS GETTING WORSE [AGGRAVATION OF EXISTING DISORDER]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF FUNCTION KIDNEY DECREASED IN A (B)(6) MALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIDENT DENTURE ADHESIVE CREAM FRESH MINT) CREAM FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED HYPERTENSION, DIABETES, HEART DISORDER AND RENAL DISEASE. IN (B)(6) 2019, THE PATIENT STARTED POLIDENT DENTURE ADHESIVE CREAM FRESH MINT 70 G AT AN UNKNOWN FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTURE ADHESIVE CREAM FRESH MINT, THE PATIENT EXPERIENCED FUNCTION KIDNEY DECREASED (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT), UREMIA (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), MENTAL IMPAIRMENT (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND AGGRAVATION OF EXISTING DISORDER. POLIDENT DENTURE ADHESIVE CREAM FRESH MINT WAS DISCONTINUED ON (B)(6) 2019 (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE FUNCTION KIDNEY DECREASED AND AGGRAVATION OF EXISTING DISORDER WERE RECOVERED/RESOLVED AND THE OUTCOME OF THE UREMIA AND MENTAL IMPAIRMENT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE FUNCTION KIDNEY DECREASED, UREMIA, MENTAL IMPAIRMENT AND AGGRAVATION OF EXISTING DISORDER TO BE RELATED TO POLIDENT DENTURE ADHESIVE CREAM FRESH MINT. ADDITIONAL DETAILS: A CONSUMER HAD BEEN USING ADHESIVE CREAM FROM EARLY (B)(6) TO (B)(6). HE BOUGHT TOTAL THREE BOXES AND HAD USED ONE WHOLE BOX ALL, 1 PER 3 OF THE OTHER BOX, AND ANOTHER BOX WAS NEW. ON (B)(6), HIS MIND WAS BLURRY AND PATIENT WAS HOSPITALIZED BECAUSE OF UREMIA THAT WAS SO SERIOUS EVEN PATIENT DID NOT KNOW WHAT PATIENT WAS SAYING. PATIENT TOOK OUT OF HIS DENTURE WHEN PATIENT WAS HOSPITALIZED. PATIENT WAS TOLD FROM THE HOSPITAL THAT HIS KIDNEY FUNCTION WAS COMPLETELY GONE SO EMERGENCY DIALYSIS WAS REQUIRED. ORIGINALLY, PATIENT HAD BAD KIDNEY, BUT AFTER USING THE ADHESIVE CREAM, THE KIDNEY WAS GETTING WORSE. THE PHYSICIAN DID NOT KNOW WHY THE KIDNEYS WERE GETTING WORSE SUDDENLY. SINCE (B)(6), PATIENT HAD STOPPED USING ADHESIVE CREAM, AND NOW PATIENT HAD RECOVERED THE KIDNEY FUNCTION A LITTLE. THE HOSPITAL SAID ANOTHER DIALYSIS COULD BE PUSHED TO LATER TIME. PATIENT WAS WONDERING THE REASON THE KIDNEY SUDDENLY GETS WORSE WAS BECAUSE PATIENT ORIGINALLY HAD BAD KIDNEY OR IF IT WAS BECAUSE OF THE ADHESIVE CREAM, OR JUST A COINCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472985 POLIDENT DENTURE ADHESIVE CREAM FRESH MINT DENTURE ADHESIVE KOT GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O