BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP/SUPER POLIGRIP ORIGINAL

    MDR report key: 2223815 · Received August 19, 2011

    Report

    Report Number
    9681138-2011-00202
    Event Type
    Other
    Date Received
    August 19, 2011
    Report Date
    August 18, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MANUFACTURED 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 MALE PT WHO USED SUPER POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATIONS INCLUDED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM AND FIXODENT. IN 1990, THE PT USED SUPER POLIGRIP AT UNK DOSING. AT AN UNK TIME AFTER USING SUPER POLIGRIP, THE PT EXPERIENCED ONE OR MORE OF THE FOLLOWING: NEUROPATHY, MYELOPATHY, PARALYSIS, KIDNEY FAILURE, LIVER FAILURE, BONE MARROW DISORDER, ANEMIA, ANKLE FRACTURE. BELL'S PALSY, ZINC TOXICITY, HYPOCUPREMIA, NEUROLOGICAL DISORDER, AND NERVE DAMAGE. TREATMENT WITH SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. ACCORDING TO THE LEGAL COMPLAINT, THE PT EXPERIENCED ONE OR MORE OF THE FOLLOWING: NEUROPATHY, MYELOPATHY, HYPERZINCURIA, ZINC TOXICITY, EXTENSIVE NERVE DAMAGE, HYPOCUPREMIA, NUMBNESS, SEVERE PAIN, TINGLING, TREMORS, CRAMPS, MUSCLE TWITCH, PARALYSIS, INABILITY TO WALK, LOSS OF BALANCE, BROKEN ANKLE, LOSS OF USE OF UPPER AND/OR LOWER EXTREMITIES, DIFFICULTY BREATHING, KIDNEY FAILURE, LIVER FAILURE, BONE MARROW DEPLETION, ABDOMINAL PAIN, NAUSEA, VOMITING, ANEMIA, LETHARGY, BELL'S PALSY, AND OTHER NEUROLOGICAL DISORDERS. THE PT "SUFFERED, AND CONTINUES TO SUFFER FROM SEVERE MENTAL AND EMOTIONAL INJURIES, INCLUDING BUT NOT LIMITED TO, SEVERE EMOTIONAL DISTRESS, DEPRESSION, ANXIETY, WORRY AND ANGUISH." THE PT "SUFFERED SEVERE AND PERMANENT PHYSICAL INJURIES, INCLUDING BUT NOT LIMITED TO PROFOUND AND PERMANENT NEUROLOGICAL INJURIES." IT WAS FURTHER REPORTED THE PT'S "INJURIES AND DAMAGES ARE PERMANENT AND WILL CONTINUE INTO THE FUTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP/SUPER POLIGRIP ORIGINAL GSK DENTURE ADHESIVE KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other