BEUDAMED
    FDA Adverse Event Other Summary report: N

    (SUPER) POLIGRIP

    MDR report key: 1943861 · Received December 23, 2010

    Report

    Report Number
    9681138-2010-00419
    Event Type
    Other
    Date Received
    December 23, 2010
    Report Date
    December 22, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (SUPER) POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE LOT NUMBER NOR THE PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED IN A NEWSPAPER ARTICLE AND DESCRIBED THE OCCURRENCE OF CRIPPLED (NEUROPATHY) IN A FEMALE PT WHO USED POLIGRIP FOR AN UNK INDICATION. ON AN UNK DATE, THE PT BEGAN USING POLIGRIP. AN UNK TIME LATER, THE PT EXPERIENCED CRIPPLED (NEUROPATHY), NERVE DAMAGE, COPPER LOW, DISABILITY, WALKING DIFFICULTY, LOSS OF FEELING IN ARM, FOOT PAIN, LOSS OF FEELING IN FEET, WEIGHT LOSS (MORE THAN THREE STONE) AND NEUROPATHY. THE PT BECAME WHEELCHAIR BOUND AND HAD NO SENSATION FROM ARMS DOWN. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT INCLUDED COPPER. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. THIS CASE IS LINKED TO CASE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (SUPER) POLIGRIP DENTURE ADHESIVE KOL GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other