BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 2426270 · Received January 18, 2012

    Report

    Report Number
    9681138-2012-00015
    Event Type
    Other
    Date Received
    January 18, 2012
    Report Date
    January 17, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A (B)(6) FEMALE PATIENT WHO USED POLIGRIP FOR 10 PLUS YEARS AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. IN 2001, THE PATIENT USED POLIGRIP AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING POLIGRIP, THE PATIENT EXPERIENCED NEUROPATHY AND COPPER LOW. THIS CASE WAS ASSESSED AS MEDICAL SERIOUS BY GSK. TREATMENT WITH POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT USED POLIGRIP FROM 2001 UNTIL THE PRESENT TIME. DIAGNOSIS INCLUDED CONFIRMED LOW COPPER AND NEUROPATHY. THE PATIENT COMPLAINED OF SERIOUS FATIGUE, SHARP PAIN, SHARP TINGLING, LOSS OF BALANCE, AND SHE DROPPED THINGS. MEDICAL RECORDS CONFIRMED A CONNECTION BETWEEN COPPER DEFICIENCY AND DENTURE CREAM. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2015-00015. SUPER POLIGRIP IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other