BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP POWDER

    MDR report key: 556440 · Received November 22, 2004

    Report

    Report Number
    9681138-2004-00034
    Event Type
    Other
    Date Received
    November 22, 2004
    Date of Event
    January 1, 1998
    Report Date
    November 19, 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 SUPER POLIGRIP POWDER. THE PT CALLED WITH A PRODUCT QUESTION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ALLERGEIS TO AMBIEN, CIPRO AND PENICILLIN. CONCURRENT MEDICATIONS INCLUDED POLIDENT DENTURE CLEANSER TABLETS, 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 9681138-2004-00034. SUPER POLIGRIP WAS MANUFACTURED BY DUNGARVAN 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 SUPER POLIGRIP POWDER DENTURE ADHESIVE EFT GLAXOSMITHKLINE CONSUMER HEALTHCARE * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O CLOPIDOGREL BISULPHATE UNK| FLUVASTATIN SODIUM UNK| POLIDENT 198 - UNK