BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP/SUPER POLIGRIP

    MDR report key: 1761199 · Received July 14, 2010

    Report

    Report Number
    9681138-2010-00258
    Event Type
    Other
    Date Received
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    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 NEUROLOGICAL INJURIES IN A MALE PT WHO USED POLIGRIP (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT USED POLIGRIP AT UNK DOSING. AT AN UNK TIME AFTER USING POLIGRIP, THE PT EXPERIENCED NEUROLOGICAL INJURIES. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. F/U INFO WAS RECEIVED ON 7/7/10 VIA A LEGAL COMPLAINT. ACCORDING TO A LEGAL COMPLAINT AND MEMORANDUM OF UNDERSTANDING, 12 PTS WERE IDENTIFIED AND MET THE FOLLOWING CRITERIA: USED SUPER POLIGRIP DENTURE ADHESIVE CREAM PRODUCTS AFTER ZINC WAS ADDED IN 1996, HAD AN ONSET OF NEUROLOGICAL SYMPTOMS AFTER SUPER POLIGRIP USE, DOCUMENTED BLOOD COPPER LEVEL(S) BELOW THE NORMAL RANGE, AND DOCUMENTED BLOOD ZINC LEVEL(S) ABOVE THE NORMAL RANGE CONCURRENT WITH SYMPTOMS OF SUPER POLIGRIP PT'S INJURIES, AND EVIDENCE OF MYELOPATHY AND/OR MYELONEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. SUPER POLIGRIP IS MFG 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/SUPER POLIGRIP DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other