BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 1960251 · Received January 5, 2011

    Report

    Report Number
    9681138-2011-00003
    Event Type
    Other
    Date Received
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    GLAXSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A (B)(6) FEMALE PT WHO USED SUPER POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT PRODUCT INCLUDED FIXODENT. IN 1995, THE PT RECEIVED FULL DENTURES. HER DENTURES ADHESIVES OF CHOICE WERE SUPER POLIGRIP AND FIXODENT. ON AN UNK DATE, THE PT "WAS DIAGNOSED WITH NEUROPATHY ATTRIBUTED TO EXCESS ZINC AND RESULTING COPPER DEPLETION ATTRIBUTABLE TO SUPER POLIGRIP AND FIXODENT." THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. ACCORDING TO THE CLAIM, THE PT'S INJURIES WERE SEVERE AND PERMANENT. SUPER POLIGRIP IS MFG IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP DENTURE ADHESIVE KOL GLAXSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other