BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2573837 · Received May 8, 2012

    Report

    Report Number
    9681138-2012-00052
    Event Type
    Other
    Date Received
    May 8, 2012
    Report Date
    May 7, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2012-00052. SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF NERVE INJURY IN A FEMALE PATIENT WHO USED SUPER POLIGRIP ORIGINAL AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT PRODUCT INCLUDED FIXODENT. IN 1996, THE PATIENT BEGAN USING SUPER POLIGRIP ORIGINAL AND FIXODENT. AN UNKNOWN TIME LATER, THE PATIENT EXPERIENCED "PROFOUND AND PERMANENT NEUROLOGICAL INJURIES." USE OF BOTH PRODUCTS CONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. FOLLOW UP INFORMATION WAS RECEIVED ON 30 APRIL 2012 VIA MEDICAL RECORDS. ON (B)(6) 2011, THE PATIENT COMPLAINED OF "I THINK I HAVE NEUROPATHY IN MY LEGS." THE PATIENT WAS IN RECOVERY FOR METHAMPHETAMINE ABUSE, WHICH WAS FOUR TO FIVE YEARS PRIOR TO HER ADMISSION. THE PATIENT HAD 90 DAYS OF CONTINUOUS SOBRIETY. THE PATIENT HAD TO HAVE ALL HER TEETH REMOVED AT (B)(6) AND HAD DENTURES AND USED FIXODENT. TWO YEARS AGO (IN 2009), SHE BEGAN HAVING NUMBNESS IN HER FEET AND DID NOT FEEL HER LEG ON THE GAS PEDAL. SHE HAD NO URINARY PROBLEMS, BUT RECENTLY HAD DEVELOPED SEVERE RESTLESS LEG SYNDROME AND WAS TAKING VALIUM FOR SLEEP. THE PATIENT ALSO COMPLAINED OF DIFFICULTY WITH FALLING AND BALANCE DIFFICULTIES, ESPECIALLY IN THE DARK. ASSESSMENT INCLUDED ZINC INDUCED MYELONEUROPATHY FROM FIXODENT (NO MENTION OF SUPER POLIGRIP ORIGINAL). ON (B)(6) 2011, THE PATIENT HAD A COPPER LEVEL OF 8 MCG/DL (NORMAL 70 TO 155) AND A ZINC LEVEL OF 192 MCG/DL (NORMAL 70 TO 150). ON (B)(6) 2011, THE PATIENT WAS STARTED ON ORAL COPPER CAPSULES, 2 MG DAILY. THIS CASE HAS BEEN UPGRADED TO MEDICALLY SERIOUS BY GSK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM TRIPLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other