BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 1993354 · Received February 5, 2011

    Report

    Report Number
    9681138-2011-00029
    Event Type
    Other
    Date Received
    February 5, 2011
    Report Date
    June 7, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2011-00029. 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 UNSPECIFIED INJURY IN A MALE PATIENT WHO USED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (SUPER POLIGRIP) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP. AN UNKNOWN TIME LATER, THE PATIENT EXPERIENCED AN UNSPECIFIED INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. MEDICAL RECORDS RECEIVED 31 JANUARY 2011: ON (B)(6) 2009, THE (B)(6)-YEAR-OLD PATIENT WAS SEEN BY A NEUROLOGIST DUE TO SUSPECTED NEUROPATHY. HE HAD NUMBNESS IN BOTH FEET WITH A SORENESS AND COLD SENSATION. THERE CAN ALSO BE A SLIGHT BURNING SENSATION, AND THIS WAS WORSE AT NIGHT. TO THAT POINT THERE HAD BEEN NO IDENTIFIABLE CAUSE, BUT THE PATIENT AND HIS WIFE HAD DISCOVERED INFORMATION ON THE INTERNET ABOUT EXCESS ZINC WITH LOW COPPER LEVELS IN INDIVIDUALS USING DENTURE ADHESIVE FOR MANY YEARS. COPPER LEVEL ON (B)(6) 2009 WAS 70 MCG/DL (NORMAL 70 TO 155). AT FOLLOW UP ON (B)(6) 2009, IT WAS NOTED THAT ELECTROPHYSIOLOGICAL STUDIES CONFIRMED EVIDENCE OF A MODERATE CHRONIC DISTAL DEMYELINATING GREATER THAN AXONAL LOSS PERIPHERAL POLYNEUROPATHY. ZINC WAS ELEVATED AT 146 (UNITS AND NORMAL VALUES NOT REPORTED) WITH A LOW COPPER LEVEL. ON (B)(6) 2009, THE PATIENT WAS SEEN BY A NEUROLOGY SPECIALIST WHO FELT HIS PICTURE WAS CONSISTENT WITH SMALL FIBER NEUROPATHY. COPPER REPLACEMENT WAS STARTED AT THAT TIME ALONG WITH B12 AND THIAMIN SUPPLEMENTATION DUE A HISTORY OF ALCOHOLISM. THE NEUROLOGIST FELT THE NEUROPATHY WAS LIKELY ALSO ALCOHOL RELATED. AT FOLLOW UP ON (B)(6) 2010, THE PATIENT'S SYMPTOMS WERE UNCHANGED. HIS COPPER AND THIAMIN LEVELS WERE STILL LOW-NORMAL AND IT WAS NOTED THE PATIENT HAD STOPPED SUPPLEMENTATION WHEN HIS PRESCRIPTIONS RAN OUT. AT FOLLOW UP ON (B)(6) 2010, THE PATIENT'S COPPER AND THIAMIN LEVELS HAD RETURNED TO NORMAL WITH NO IMPROVEMENT IN HIS SYMPTOMS. IT WAS NOTED THAT B12 AND COPPER DEFICIENCY WERE PROBABLY ATTRIBUTED TO POLIGRIP USE, AND THE PATIENT HAD SWITCHED TO USING ZINC-FREE POLIGRIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other