BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2170177 · Received June 27, 2011

    Report

    Report Number
    9681138-2011-00154
    Event Type
    Other
    Date Received
    June 27, 2011
    Date of Event
    January 1, 2004
    Report Date
    June 24, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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 MALE PATIENT WHO USED SUPER POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT BEGAN USING SUPER POLIGRIP. AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), THE PATIENT EXPERIENCED NEUROLOGICAL INJURIES. AT THE TIME OF REPORTING, THE OUTCOME OF THIS EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(4) 2011 VIA MEDICAL RECORDS. ON (B)(6) 2006, A CERVICAL SPINE MAGNETIC RESONANCE IMAGING (MRI) SHOWED POSSIBLE MILD SPINAL CANAL STENOSES. AN UNDERLYING MYELOPATHY CANNOT BE SPECIFIED. ON (B)(6) 2006, THE PATIENT HAD FOLLOW UP OF GAIT ATAXIA AND SUSPECTED CERVICAL MYELOPATHY. ON (B)(6) 2009, IT WAS REPORTED THE PATIENT HAD BEEN ON POLIGRIP FOR 30 YEARS. THE PATIENT HAD UNEXPLAINED NUMBNESS AND TINGLING IN HIS HANDS AND FEET, UNSTEADY GAIT, AND JOINT PAIN ALL FOR THREE TO FOUR YEARS (SINCE APPROXIMATELY 2005/2006). ON (B)(6) 2009, THE PATIENT REQUESTED COPPER AND ZINC LEVEL TESTING AFTER SEEING A TELEVISION AD. HE BELIEVED HE WAS POISONED AND HIS NUMBNESS AND TINGLING WAS RELATED TO THAT. DIAGNOSIS INCLUDED TYPE TWO DIABETES MELLITUS WITH NEUROPATHY. ON (B)(6) 2009, THE PATIENT WAS INSTRUCTED TO STOP TAKING POLIGRIP OR ANY MEDICATIONS/MULTIVITAMINS CONTAINING ZINC. ON (B)(6) 2009, THE PATIENT COMPLAINED OF TINGLING IN FEET AND HANDS AND COMPLAINED THAT HE COULD NOT TELL WHERE HIS FEET WERE. THE PATIENT USED A WALKER FOR AMBULATION. THE PATIENT COMPLAINED OF BOTH FEET AND HANDS BEING NUMB FOR FOUR TO FIVE YEARS (SINCE APPROXIMATELY 2004/2005). THE PATIENT STATED THAT HE GOT ZINC POISONING FROM POLIGRIP. ON (B)(6) 2009, PATIENT PROBLEMS INCLUDED PERIPHERAL NEUROPATHY. THE PATIENT WAS EVALUATED FOR A SCOOTER. THE PATIENT USED TO BE VERY SHORT OF BREATH AND WHEELCHAIR BOUND. THE PATIENT HAD A VERY UNSTEADY GAIT, WEAK LOWER EXTREMITIES, HAD FALLEN MANY TIMES AT HOME, AND NEEDED ASSISTANCE TO TRANSFER FROM ONE PLACE TO ANOTHER. THIS CASE WAS UPGRADED TO MEDICALLY SERIOUS BY GSK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other