BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIGRIP DENTURE ADHESIVE CREAM, CUSHION AND COMFORT, ZINC FREE

    MDR report key: 15626448 · Received October 17, 2022

    Report

    Report Number
    MW5112698
    Event Type
    Injury
    Date Received
    October 17, 2022
    Date of Event
    August 5, 2022
    Report Date
    October 14, 2022
    Manufacturer
    GSK / GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PURCHASED A POLIDENT DENTURE ADHESIVE PRODUCT (B)(6) 2023 AND NOTICED IT DID NOT WORK AS IT SHOULD. IT WAS KIND OF RUNNY AND CONSTANTLY OOZED OUT FROM UNDER MY DENTURE. BY THE BEGINNING (B)(6) 2022 I WAS QUITE ILL TO THE POINT WHERE I STAYED IN BED A LOT. I JUST FELT AWFUL AND DIDN'T KNOW WHY. LIKE A STRANGE FLU WITHOUT THE USUAL FLU SYMPTOMS. CONTACTED MY DOCTOR WHO RAN BLOOD TEST BUT NOTHING WAS OBVIOUS EXCEPT ELEVATED MYOCITES. NO TOXICOLOGY TEST WERE RAN. WHILE TRYING TO FIGURE OUT WHAT WAS MAKING ME SO ILL IT DAWNED ON ME THAT IT BEGAN ABOUT THE SAME TIME I BEGAN USING THE POLIDENT. I STOPPED USING IT TOWARD THE END OF (B)(6) AND WITHIN A FEW DAYS I BEGAN TO FEEL BETTER AND NO LONGER FELT ILL. I WISHED I COULD HAVE HAD THE PRODUCT TESTED BUT DID NOT KNOW WHO TO CONTACT. I DO STILL HAVE AT LEAST 3 OR 4 UNUSED TUBES OF IT AS I HAD BOUGHT IT AS A MULTI-PACK. I REALLY BELIEVE SOMETHING IN THIS PRODUCT WAS VERY BAD BECAUSE IT ALMOST MADE ME GO TO THE EMERGENCY ROOM BECAUSE I FELT SO ILL. A FEW DAYS AGO I RECEIVED AN EMAIL STATING THAT THERE IS AN ACTIVE RECALL ON THIS PRODUCT FROM IMPROPER STORAGE. I BELIEVE THERE IS MORE TO THIS PROBLEM. THE RECALL NUMBER IS Z-1539-2022 ID IS (B)(4). THE PROBLEM STOPPED AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT. APPLIED TO DENTURE. TO HOLD DENTURE IN PLACE. DATES OF USE: (B)(6) 2022 - (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047245 POLIGRIP DENTURE ADHESIVE CREAM, CUSHION AND COMFORT, ZINC FREE ADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (32%) AND ETHYLENE-OXIDE HOMOPO KOL GSK / GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. 160230

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Disability