BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 1981364 · Received February 2, 2011

    Report

    Report Number
    9681138-2011-00026
    Event Type
    Other
    Date Received
    February 2, 2011
    Report Date
    February 1, 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 MFG 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 VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF ZINC TOXICITY IN A 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 1998, THE PT BEGAN USING SUPER POLIDENT AND FIXODENT. AN UNK TIME LATER, THE PT EXPERIENCED "ZINC TOXICITY, HYPOCUPREMIA, AND EXTENSIVE NERVE DAMAGE RESULTING IN SYMPTOMS THAT INCLUDE SEVERE PAIN AND STINGING IN HER HANDS, LEGS, FEET AND ARMS, NUMBNESS IN HANDS AND TORSO FROM THE WAIST DOWN, MUSCLE WEAKNESS AND BALANCE PROBLEMS." USE OF SUPER POLIGRIP AND FIXODENT WAS CONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. MEDICAL RECORDS RECEIVED 27 JAN 2011: ON (B)(6) 2010, THE (B)(6) PT WAS SEEN BY A NEUROLOGIST FOR PAIN AND NUMBNESS OF HER HANDS AND FEET THAT SHE HAD BEEN EXPERIENCING FOR SEVERAL MONTHS. THE PT HAD BEEN DROPPING THINGS WITH HER HANDS AND HAD DIFFICULTY WITH GAIT WITH LOSS OF BALANCE. SHE HAD TO HOLD ONTO FURNITURE TO MAKE IT ACROSS A DARK ROOM AND WAS UNABLE TO MAINTAIN AN UPRIGHT POSTURE. THE PHYSICIAN NOTED THE PT HAD NO NEUROPATHY RISK FACTORS, BUT SHE HAD ASKED THE PHYSICIAN ABOUT HER USE OF POLIGRIP AS SHE HAD HEARD ON THE NEWS ABOUT PEOPLE HAVING SIMILAR SYMPTOMS. SHE WAS DIAGNOSED WITH A LARGE FIBER SENSORY NEUROPATHY WITH VIBRATION IMPAIRED IN BOTH UPPER AND LOWER EXTREMITIES AND DEFINITE EVIDENCE OF PROPRIOCEPTION DIFFICULTIES WITH A POSITIVE ROMBERG. AT A PHYSICIAN VISIT ON (B)(6) 2010, IT WAS NOTED THE PT HAD INCREASED ZINC LEVELS WITH URINE ZINC AT 4011 (NORMAL 150 TO 2000) SECONDARY TO DENTURE CREAM. THIS CASE WAS NOW CONSIDERED MEDICALLY SERIOUS BY GSK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other