BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2366310 · Received December 5, 2011

    Report

    Report Number
    9681138-2011-00261
    Event Type
    Other
    Date Received
    December 5, 2011
    Report Date
    December 5, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 AND DESCRIBED THE OCCURRENCE OF EPILEPSY IN A FEMALE PATIENT WHO USED SUPER POLIGRIP ORIGINAL AS A DENTURE ADHESIVE CREAM. CO-SUSPECT MEDICATION INCLUDED FIXODENT. IN 1989, THE PATIENT USED SUPER POLIGRIP ORIGINAL AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING SUPER POLIGRIP ORIGINAL, THE PATIENT EXPERIENCED EPILEPSY, SEIZURE, HEADACHE, AND COPPER HIGH. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP ORIGINAL WAS DISCONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. INFORMATION WAS RECEIVED ON 11/28/2011 VIA FACT SHEETS COMPLETED BY THE PATIENT AND/OR THE PATIENT'S ATTORNEY. SUPER POLIGRIP ORIGINAL WAS USED FROM 1989 UNTIL 1993, ONE TO THREE TIMES A DAY, ONE 2.4 OUNCE TUBE A WEEK. FIXODENT FREE WAS USED IN 1989 UNTIL AN UNKNOWN DATE, ONE TO THREE TIMES A DAY, ONE 2.4 OUNCE TUBE A WEEK. SEA BOND WAS USED ON UNKNOWN DATES. THE PATIENT EXPERIENCED EPILEPSY/SEIZURES (1999) AND HEADACHES (2000). ON (B)(6) 2010, THE PATIENT'S COPPER LEVEL WAS 166 MCG/DL (NORMAL 70 TO 155) AND ZINC LEVEL WAS 98 MCG/DL (NORMAL 70 TO 150).

    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