BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2111187 · Received May 26, 2011

    Report

    Report Number
    9681138-2011-00132
    Event Type
    Other
    Date Received
    May 26, 2011
    Report Date
    May 25, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MFG 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 NEUROPATHY IN A FEMALE PT WHO USED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED FIXODENT. IN (B)(6) 1988, THE PT USED SUPER POLIGRIP ORIGINAL. AT AN UNK TIME AFTER USING SUPER POLIGRIP ORIGINAL, THE PT EXPERIENCED NEUROPATHY, ZINC HIGH, AND COPPER LOW. 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 UNK. INFO WAS RECEIVED ON 5/23/2011 VIA FACT SHEETS SUBMITTED BY THE PT AND/OR PT'S ATTORNEY. THE PT RECEIVED DISABILITY FOR AN UNK CAUSE. THE PT EXPERIENCED HIGH ZINC, LOW COPPER, NEUROPATHY, LOSS OF FEELING IN FEET/LEGS/HANDS, COULD NO LONGER WALK, CONSTANTLY DROPPED THINGS, AND USED A WHEELCHAIR. THE PT RECEIVED INTRAVENOUS COPPER TREATMENT IN (B)(6) 2005 AND OCCUPATIONAL THERAPY FROM (B)(6) 2005. THE PT FIRST USED PARTIAL LOWER DENTURES IN (B)(6) 1988. THE PT USED SUPER POLIGRIP ORIGINAL FROM (B)(6)1988 UNTIL 2005 (FIVE TO SIX TIMES A DAY, ONE TO TWO 2.4 OUNCE TUBES WEEKLY), FIXODENT ORIGINAL FROM 2005 UNTIL 2010 (FIVE TO SIX TIMES A DAY, ONE TO TWO 2.4 OUNCE TUBES WEEKLY), AND POLIGRIP ZINC FREE FROM 2010 UNTIL THE TIME OF THIS REPORT.

    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