BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2366302 · Received December 5, 2011

    Report

    Report Number
    9681138-2011-00260
    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 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 USED SUPER POLIGRIP AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING SUPER POLIGRIP, THE PATIENT EXPERIENCED NERVE INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2011, VIA FACT SHEETS COMPLETED BY THE PATIENT AND/OR THE PATIENT'S ATTORNEY. SUPER POLIGRIP ORIGINAL WAS SUED FROM 2000 UNTIL AN UNKNOWN TIME, TWICE DAILY, ONE 2.4 OUNCE TUBE A WEEK. SUPER POLIGRIP ZINC FREE FORMULA WAS USED FROM AN UNKNOWN DATE UNTIL THE TIME OF THIS REPORT. THE PATIENT EXPERIENCED NEUROPATHY (2006). THE PATIENT ALSO EXPERIENCED A FEAR OF FUTURE INJURY, HIGH CHOLESTEROL, STOMACH IRRITATION, DIZZINESS, DROWSINESS, A LOT OF SWEATING, ANEMIA, AND MUSCLE LOSS. ON (B)(6) 2011, NERVE CONDUCTION STUDIES (NCV) AND AN ELECTROMYOGRAM (EMG) SHOWED BILATERAL L3/4 AND L4/5 ROOT IRRITABILITY OR EARLY COMPRESSION, CONSISTENT WITH STENOSIS OR ROOT IRRITATION BILATERALLY WORSE ON THE RIGHT SIDE AND DIABETIC NEUROPATHY NOTED. ON (B)(6) 2010, THE PATIENT'S COPPER AND ZINC LEVELS WERE NORMAL. THIS CASE HAS BEEN UPGRADED TO MEDICALLY SERIOUS BY GSK.

    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