BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2101180 · Received May 18, 2011

    Report

    Report Number
    9681138-2011-00123
    Event Type
    Other
    Date Received
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A TOLLING AGREEMENT AND DESCRIBED THE OCCURRENCE OF NERVE INJURY IN A FEMALE PATIENT WHO RECEIVED POLIGRIP (FORMULATION UNKNOWN) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIGRIP (DENTAL). AT AN UNKNOWN TIME AFTER STARTING POLIGRIP, THE PATIENT EXPERIENCED NERVE INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE FOLLOWING INFORMATION WAS RECEIVED ON (B)(4) 2011, VIA FACT SHEETS COMPLETED BY THE PATIENT AND/OR THE PATIENT'S REPRESENTATIVE AND THE REPORTING ATTORNEY. THE PATIENT USED SUPER POLIGRIP ORIGINAL 3 TO 4 TIMES DAILY FROM (B)(6) 2005 TO (B)(6) 2009, USING ONE TO ONE AND A HALF 2.4-OUNCE TUBE(S) WEEKLY, AND FIXODENT FOR ONE WEEK IN (B)(6) 2005. THE PATIENT EXPERIENCED NUMBNESS IN THE LEGS AND FEET, WEAKNESS, POOR BALANCE, DIFFICULTY MAKING THE LEGS MOVE, INABILITY TO DRIVE, POOR REFLEXES, INABILITY TO WALK FAR, INABILITY TO STAND LONG, INABILITY TO SIT LONG, FEELING UNCOMFORTABLE, HIGH ZINC, LOW COPPER, NEUROPATHY IN THE LEGS AND FEET ((B)(6) 2007), PROGRESSIVE WEAKNESS WITH SEVERE LEG NUMBNESS IN (B)(6) 2009, FOOT NUMBNESS, LOWER BODY WEAKNESS, AND REQUIRED USE OF A WALKER. THIS CASE WAS NOW CONSIDERED MEDICALLY SIGNIFICANT 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