BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2519806 · Received March 28, 2012

    Report

    Report Number
    9681138-2012-00044
    Event Type
    Other
    Date Received
    March 28, 2012
    Report Date
    March 27, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2012-00044. 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 PT WHO USED SUPER POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT BEGAN USING SUPER POLIGRIP. AN UNK TIME LATER, THE PT EXPERIENCED UNSPECIFIED NEUROLOGICAL INJURIES. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. FOLLOW UP INFO WAS RECEIVED ON 20 MARCH 2012 VIA MEDICAL RECORDS. ON (B)(6) 2010, THE PT DEVELOPED SOME CONTINUED STIFFNESS, UNUSUAL HAND SENSATION, DIFFICULTY USING HIS HANDS, AS WELL AS SOME GAIT DISTURBANCE. A NEUROSURGEON FELT HE HAD A HERNIATED NUCLEUS PULPOSUS (HNP) OF C5/C6 WITH SOME ANTERIOR CORD COMPRESSION AND SOME SPINAL STENOSIS. HE WAS TREATED CONSERVATIVELY WITH A CERVICAL COLLAR. THE PT BOUGHT A CANE FOR STABILITY AND ALSO NOTED SOME PROBLEMS WITH URINARY URGENCY. THE PT HAD PREVIOUSLY RECEIVED A CORTISONE SHOT IN THE KNEE. THE PT WAS CONCERNED ABOUT ZINC TOXICITY DUE TO "FIXODENT" (LATER CORRECTED TO REFLECT A HISTORY OF SUPER POLIGRIP USE) USE CHRONICALLY WITH CORRESPONDING DROP IN COPPER LEVELS. THE PT HAD BEEN USING "FIXODENT" SINCE ABOUT TWO YEARS AGO AND THOUGHT HE HAD SOME MILDER PROBLEMS DATING BACK TO THAT TIME. THE PT'S DENTURE ADHESIVE WAS DISCONTINUED AND COPPER REPLACEMENT WAS STARTED. ON (B)(6) 2010, THE PT HAD A SENSATION OF POOR BALANCE AND USED A CANE FOR STABILITY. ON (B)(6) 2010, THE PT HAD A SENSATION OF PRESSURE AROUND HIS TORSO, AROUND FROM FRONT TO BACK. ON (B)(6) 2010, MYELOPATHY SYMPTOMS WERE NO BETTER AND HE FELT ME MIGHT BE A BIT WORSE. ON (B)(6) 2010, THE PT HAD RECEIVED COPPER INFUSIONS FOR FIVE DAYS WITH 3 MG OF ELEMENTAL COPPER. ON (B)(6) 2011, THE PT HAD RECEIVED INTRAVENOUS COPPER AT A HIGH DOSE IN THE HOSPITAL AFTER KNEE SURGERY AND HIS LEVELS HAD NORMALIZED. UNFORTUNATELY, HE DID NOT NOTE ANY IMPROVEMENT IN BALANCE AND FINGER SENSATION WAS STILL ALTERED. HE HAD NOT NOTED ANY CHANGE IN BALANCE OR GAIN IN THE LAST THREE MONTHS AND NONE SINCE COPPER LEVELS WERE BACK UP. THE PT REMAINED ON ORAL COPPER. ON (B)(6) 2011, THE PT'S COPPER LEVEL HAD DRIFTED DOWNWARD SINCE HIS INTRAVENOUS INFUSIONS. COPPER GLUCONATE WAS INCREASED TO 4 MG A DAY. ON (B)(6) 2012, THE PT WAS NOTED TO HAVE USED SUPER POLIGRIP IN THE PAST FOR A YEAR OR TWO AND DEVELOPED HIS MYELOPATHY SYMPTOMS WHICH LATER WERE DETERMINED TO BE DUE TO COPPER MALABSORPTION FROM THE ZINC IN THE DENTURE CREAM IN THE SETTING OF HIS GASTRIC BYPASS. THE PT HAD NO PROBLEMS FOR 30 YEARS PRIOR TO THE INTRODUCTION OF THE ZINC CONTAINING CREAM AND THEN HAD A DROP IN COPPER LEVELS DUE TO THE WORSENED COPPER MALABSORPTION FROM THE ZINC. THIS THEN RESULTED IN HIS ACUTE MYELOPATHY TYPE SYMPTOMS. THE PT HAD A NORMAL ZINC LEVEL IN (B)(6) 2010 AND HAD BEEN OFF SUPER POLIGRIP FOR THREE MONTHS PRIOR TO THE LEVEL BEING DRAWN. PAST MEDICAL HISTORY INCLUDED CERVICAL SPONDYLOSIS WITH MYELOPATHY VERSUS MYELONEUROPATHY DUE TO COPPER DEFICIENCY. THE PT WAS HAVING ONGOING NEURO-MYELOPATHY SYMPTOMS IN HIS FINGERS, HANDS, AND LEGS. THIS CASE HAS BEEN 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 Other