BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP/SUPER POLIGRIP

    MDR report key: 2222529 · Received August 4, 2011

    Report

    Report Number
    9681138-2011-00190
    Event Type
    Other
    Date Received
    August 4, 2011
    Date of Event
    January 1, 1998
    Report Date
    August 3, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (SUPER) POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE LOT NUMBER NOR THE PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NUMBNESS IN FEET AND TOES IN A FEMALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (POLIGRIP) FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE PATIENT HAD USED POLIGRIP FOR MANY YEARS. ON AN UNKNOWN DATE, THE PATIENT STARTED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (UNKNOWN). IN 2006, THE PATIENT EXPERIENCED NUMBNESS IN FEET AND TOES, LOSS OF BALANCE, BLOOD PRESSURE ABNORMAL AND ABNORMAL HEART RATE. IN THE LAST TWO YEARS, THE SYMPTOMS "HAD DRAMATICALLY INCREASED." THE PATIENT HAD CONSULTED HER DOCTOR. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. ADDITIONAL INFORMATION FROM COMPUTERISED MEDICAL RECORDS RECEIVED (B)(4) 2011: IT WAS NOTED IN THE RECORDS PROVIDED (DATED (B)(4) 2006) THAT THE PATIENT HAD EXPERIENCED PANIC ATTACKS WITH PALPITATIONS AND SHAKING, AND COULD NOT IDENTIFY THE TRIGGER. IT WAS RECORDED ON (B)(4) 2010 THAT THE PATIENT HAD "NUMBNESS IN FINGERS AND TOES - THOUGHT TO BE DUE TO DENTAL FIXATIVE 'POLIGRIP' - NOW USING 'FIXODENT' - STILL GETTING NUMBNESS IN TOES. HAD NUMBNESS FOR 10 YEARS, USING POLIGRIP FOR THIS TIME - SINCE 1984 - WAS USING QUITE A LOT LAST YEAR UNTIL NEW DENTURES MADE LAST YEAR." BLOOD TESTS ON (B)(6) 2010 SHOWED SERUM VITAMIN B12 607 NG/L (NORMAL RANGE 191-663) AND SERUM FOLATE 18.9 UG/L (NORMAL RANGE 4.6-18.7). NO REFERENCE TO ANY TESTS FOR COPPER AND/OR ZINC LEVELS IN BLOOD WAS IDENTIFIED IN THE RECORDS PROVIDED. THE PATIENT PROVIDED A STATEMENT OF CIRCUMSTANCES IN WHICH SHE REPORTED THAT SHE HAD BEEN USING POLIGRIP SINCE 1984 AND HAD NOTICED A GENERAL DETERIORATION IN HER HEALTH SINCE 1998. IN 2006, THE PATIENT REPORTED SYMPTOMS OF NUMBNESS IN FINGERS AND TOES, DIZZINESS, FAINTING, LOSS OF BALANCE, INCREASING NERVOUSNESS, IRRITABILITY, LOSS OF CONCENTRATION AND FORGETFULNESS. THIS CASE WAS ASSESSED AS BEING MEDICALLY SERIOUS BY GSK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP/SUPER POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other