BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

    MDR report key: 3557296 · Received December 20, 2013

    Report

    Report Number
    1020379-2013-00014
    Event Type
    Other
    Date Received
    December 20, 2013
    Report Date
    December 19, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CELIAC SPRUE IN A FEMALE PATIENT WHO USED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CELIAC SPRUE. CO-SUSPECT MEDICATION INCLUDED POLIDENT FOR PARTIALS DENTURE CLEANSER TABLETS, SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM AND POLIGRIP FOR PARTIALS SEAL AND PROTECT. ON AN UNKNOWN DATE, THE PATIENT USED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS (DENTAL) AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS, THE PATIENT EXPERIENCED CELIAC SPRUE AND CONDITION AGGRAVATED. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CONDITION AGGRAVATED WAS LOGGED BECAUSE SHE SAID HER CELIAC SPRUE WAS REACTING AND GETTING WORSE. CONSUMER WAS NOT SURE WHICH PRODUCT WAS MAKING HER CELIAC SPRUE REACT. THE MANUFACTURER'S REPORT NUMBER FOR THE FIRST PRODUCT IN THIS CASE IS 1020379-2013-00014. THE POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS ARE MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. THE MANUFACTURER'S REPORT NUMBER FOR THE SECOND PRODUCT IN THIS CASE IS 1020379-2013-00015. POLIDENT FOR PARTIALS DENTURE CLEANSER TABLETS ARE MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. THE MANUFACTURER'S REPORT NUMBER FOR THE THIRD PRODUCT IN THIS CASE IS 9681138-2013-00035. SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT (V13247) IS AVAILABLE; HOWEVER, IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. THE MANUFACTURER'S REPORT NUMBER FOR THE (B)(4) PRODUCT IN THIS CASE IS 9681138-2013-00036. POLIGRIP FOR PARTIALS SEAL AND PROTECT IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT (V13112) IS AVAILABLE; HOWEVER, IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668957 POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS DOUBLE SALT DENTURE CLEANSER EFT GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other