BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP/SUPER POLIGRIP

    MDR report key: 2011708 · Received March 3, 2011

    Report

    Report Number
    9681138-2011-00056
    Event Type
    Other
    Date Received
    March 3, 2011
    Report Date
    March 2, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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 AND DESCRIBED THE OCCURRENCE OF COPPER DEFICIENCY IN A MALE PATIENT WHO USED POLIGRIP (FORMULATION UNKNOWN) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT USE POLIGRIP AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING POLIGRIP, THE PATIENT EXPERIENCED COPPER DEFICIENCY, ZINC POISONING, AND NERVE INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. ACCORDING TO A LEGAL CLAIM, THERE WERE 26 PATIENTS WHO REPORTED BEING REGULAR USERS OF ZINC-CONTAINING POLIGRIP OR A COMBINATION OF ZINC-CONTAINING POLIGRIP AND FIXODENT. ALL OF THE PATIENTS EXPERIENCED "NEUROLOGICAL MANIFESTATIONS OF ZINC-INDUCED COPPER DEFICIENCY." THE ATTORNEYS BELIEVED THAT THEIR "CLIENTS" USE OF POLIGRIP WAS THE SUBSTANTIAL AND PROVABLE CAUSE OF THEIR INJURIES." FOLLOW UP INFORMATION WAS RECEIVED ON (B)(4) 2010 VIA LEGAL COMPLAINT COMPLETED BY THE PATIENT AND HIS ATTORNEY. THE (B)(6) PATIENT USED SUPER POLIGRIP (FORMULATION UNKNOWN) PRIMARILY, AND FIXODENT BEGINNING IN 2000 AFTER HE HAD BECOME DENTURE DEPENDENT. THE PATIENT CEASED THE USE OF SUPER POLIGRIP AND FIXODENT IN OR ABOUT 2010, AFTER HE WAS DIAGNOSED TO HAVE EXCESS ZINC AND RESULTING COPPER DEPLETION, ATTRIBUTABLE TO SUPER POLIGRIP AND FIXODENT. THE PATIENT NOW "SUFFERS FROM PROFOUND AND PERMANENT NEUROLOGICAL AND OTHER INJURIES" AND WAS UNABLE TO PERFORM HIS "NORMAL, CUSTOMARY AND DAILY ACTIVITIES." FOLLOW UP INFORMATION WAS RECEIVED ON 28 FEBRUARY 2011 VIA MEDICAL RECORDS. ON (B)(6) 2010, THE PATIENT'S ATTORNEY WAS WORRIED ABOUT HIS DENTURE CREAM CAUSING THE PATIENT'S NUMBNESS. THE PATIENT'S ZINC LEVEL WAS 83 (NORMAL 70 TO 150 UG/DL) AND COPPER LEVEL WAS 53 (NORMA,L 70 TO 155 UG/DL). ON (B)(6) 2010, ELECTROMYOGRAPHY (EMG) AND NERVE CONDUCTION STUDIES (NCS) SUGGESTED A SENSORY GREATER THAN MOTOR, DISTAL LOWER EXTREMITY, PREDOMINANTLY AXONAL PERIPHERAL NEUROPHATHY. THE CASE WAS UPGRADED AND ASSESSED AS MEDICAL SERIOUS BY GSK. THE PATIENT HAD A HISTORY OF PRIOR LOWER BACK FRACTURES, WITH DECREASED ABILITY TO AMBULATE. ON (B)(6) 2010, THE PATIENT WAS SEEN IN FOLLOW UP WITH COMPLAINTS OF NUMBNESS THAT HAD BEEN OCCURRING IN A PERSISTENT PATTERN FOR YEARS AND WAS NOW INCREASING. THE NUMBNESS WAS LOCATED IN BOTH FEET/HANDS AND OCCASIONALLY CAUSED THE PATIENT TO HAVE A HARD TIME WALKING AND HE GOT UNBALANCED. ON (B)(6) 2010, THE PATIENT WAS EVALUATED IN A FOOT CENTER WITH FOOT PAIN. THE PATIENT COMPLAINED OF NUMBNESS AND BURNING FOR THE PAST TWO TO THREE YEARS (SINCE 2007/2008). THE PATIENT REPORTED HAVING PERIPHERAL NEUROPATHY IN HIS LOWER LEG, FEET, AND HANDS. THE PATIENT WAS DIAGNOSED BY A NEUROLOGIST APPROXIMATELY THREE TO FOUR MONTHS PRIOR. THE PATIENT STATED THAT MEDICATION HAD HELPED WITH THE BURNING AND THE PINS AND NEEDLE FEELING, BUT THE TINGLING AND NUMBNESS SENSATIONS IN HIS FEET AND LEGS CONTINUED. THE PATIENT WAS BEING TREATED WITH GABAPENTIN. THE PATIENT HAD A HISTORY OF WARTS ON THE BOTTOM OF HIS FEET THAT HIS PRIMARY CARE PHYSICIAN HAD BEEN FREEZING OFF AND HE HAD BEEN USING AN OVER THE COUNTER WART REMOVER FOR THE WARTS AS WELL (PARTS OF RECORD ILLEGIBLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP/SUPER POLIGRIP DENTURE ADHESIVE CREAMS KOL GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FIXODENT