BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT DENTURE ADHESIVE CREAM

    MDR report key: 3181973 · Received June 14, 2013

    Report

    Report Number
    9681138-2013-00011
    Event Type
    Other
    Date Received
    June 14, 2013
    Date of Event
    March 1, 2013
    Report Date
    June 13, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POLIDENT DENTURE ADHESIVE CREAM (DISTRIBUTED AS SUPER POLIGRIP DENTURE ADHESIVE CREAM IN THE UNITED STATES) IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF DYSREGULATED DIABETES (DISTURBED CONTROL OF DIABETES) IN A (B)(6) FEMALE PT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIDENT DENTURE ADHESIVE CREAM) CREAM FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED DIABETES WHICH SHE HAD FOR ABOUT 10 YEARS AND THAT WAS STABLE WITH TREATMENT (NOS). THE PT ALSO HAD TREATMENT FOR HER THYROID WHICH SHE HAD BEEN RECEIVING FOR THE PAST 25 YEARS APPROXIMATELY. CONCURRENT MEDICATIONS INCLUDED TREATMENT FOR DIABETES (NOS) AND SODIUM LEVOTHYROXINE (LEVOTHYROX) FOR HER THYROID. IN (B)(6) 2013, THE PT STARTED DOUBLE SALT DENTAL ADHESIVE CREAM (DENTAL) (UNKNOWN BATCH) FOR THE FIRST TIME TO FIX HER DENTURES. IT WAS NOTED THAT THE PT APPLIED DOUBLE SALT DENTAL ADHESIVE CREAM SEVERAL TIMES PER DAY TO HER DENTURES (NON RESPECT OF INSTRUCTIONS OF USE). IMMEDIATELY OR POSSIBLY THE DAY AFTER STARTING DOUBLE SALT DENTAL ADHESIVE CREAM, IN (B)(6) 2013, THE PT'S DIABETES CONTROL WAS DISTURBED WITH INCREASE OF BLOOD GLUCOSE LEVEL. THE PT EXPERIENCED DYSREGULATED DIABETES (DISTURBED CONTROL OF DIABETES). THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. ON AN UNKNOWN DATE, GLYCEMIA WAS REPORTED TO HAVE INCREASED UP TO 4.40 G/L. THE PT CONSULTED HER DOCTOR WHO INCREASED THE DOSAGE OF HER DIABETES TREATMENT (FROM ONE TO TWO TABLETS). AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270887 POLIDENT DENTURE ADHESIVE CREAM DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other LEVOTHYROX (UNK)| DIABETES MEDICATION (UNK)