BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT

    MDR report key: 556434 · Received November 22, 2004

    Report

    Report Number
    1020379-2004-00010
    Event Type
    Other
    Date Received
    November 22, 2004
    Date of Event
    January 1, 1993
    Report Date
    November 17, 2004
    Manufacturer
    GLAXOSMITHKLINE CONSUMER HEALTHCARE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF STROKE IN A PT WHO RECEIVED POLIDENT DENTURE CLEANSER TABLETS. THE PT CALLED WITH A PRODUCT QUESTION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ALLERGIES TO AMBIEN, CIPRO AND PENICILLIN. CONCURRENT MEDICATIONS INCLUDED SUPER POLIGRIP POWDER, BABY ASPIRIN, ACTONEL, PLAVIX, NEXIUM AND LESCOL. PAST MEDICAL HISTORY INCLUDED DIVERTICULITIS. IN 1984 THE PT STARTED USING POLIDENT DENTURE CLEANSER TABLETS FOR DENTURE DISCOLORATION. IN 1993, THE PT WAS VOMITING AND WAS TAKEN TO THE ER WHERE THEY WERE DIAGNOSED AS HAVING A STROKE DUE TO A BLOOD CLOT IN THEIR BRAIN; THEY WERE HOSPITALIZED FOR 6 WEEKS AND AN "ANGIOPLASTY" WAS DONE. THE EVENT RESOLVED BUT THE PT HAD PARTIAL PARALYSIS FOR WHICH THEY RECEIVED SPEECH AND PHYSICAL THERAPY. DURING THIS YEAR THEY WERE DIAGNOSED WITH ANGINA AND HIGH CHOLESTOEROL. IN 1999 THEY REPORTED THAT THEY WERE DIAGNOSED WITH OSTEOARTHRITIS AND OSTEOPOROSIS AND IN 2002 WAS DIAGNOSED WITH A ACID REFLUX. IN 2004, THE PT SUFFERED A "MINISTROKE" DUE TO A CLOT IN THEIR HEART THAT WENT TO THE BRAIN; THEY WERE TREATED WITH PLAVIX. THE EMBOLIC STROKE RESOLVED WITH SEQUELAE; THE BLOOD CLOT, "MINISTROKE," AND VOMITING RESOLVED. ALL OTHER EVENTS ARE UNRESOLVED. THE USE OF POLIDENT TABLETS AND SUPER POLIGRIP POWDER WAS CONTINUED. MFR'S COMMENT: THE MFR'S REPORT NUMBER FOR THIS CASE IS 1020379-2004-00010. POLIDENT DENTURE CLEANSER TABELTS WERE MANUFACTURED BY MEMPHIS, AND NEITHER THE LOT NUMBER NOR PRODUCT ARE AVIALABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT DENTURE CLEANSER TABLETS EFT GLAXOSMITHKLINE CONSUMER HEALTHCARE * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O SUPER POLIGRIP POWDER, 1998.