BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP/SUPER POLIGRIP ORIGINAL

    MDR report key: 2214073 · Received July 19, 2011

    Report

    Report Number
    9681138-2011-00176
    Event Type
    Other
    Date Received
    July 19, 2011
    Report Date
    July 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 ZINC TOXICITY IN A MALE PATIENT WHO USED SUPER POLIGRIP (FORMULATION UNKNOWN) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM (FORMULATION NUMBER (B)(4)) AND FIXODENT. IN 1997, THE PATIENT USED SUPER POLIGRIP AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING SUPER POLIGRIP, THE PATIENT EXPERIENCED ZINC TOXICITY, NERVE DAMAGE, LOSS OF BALANCE, NUMBNESS OF EXTREMITIES, PAIN IN EXTREMITY, TINGLING OF EXTREMITY, WEAKNESS IN EXTREMITY, DIZZINESS, AND FATIGUE. TREATMENT WITH SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT EXPERIENCED "ZINC TOXICITY AND EXTENSIVE NERVE DAMAGE RESULTING IN LOSS OF BALANCE, NUMBNESS, PAIN, TINGLING AND WEAKNESS IN LEGS, HANDS, ARMS AND FEET, DIZZINESS AND FATIGUE." THE PATIENT "SUFFERED SEVERE AND PERMANENT PHYSICAL INJURIES, INCLUDING BUT NOT LIMITED TO PROFOUND AND PERMANENT NEUROLOGICAL INJURIES." IT WAS FURTHER REPORTED THE PATIENT'S INJURIES AND DAMAGES ARE PERMANENT AND WILL CONTINUE INTO THE FUTURE." MEDICAL RECORDS RECEIVED 18 MAY 2011: ON (B)(6) 2006, THE PATIENT WAS SEEN WITH A SEVERAL MONTH HISTORY OF INTERMITTENT PAIN, NUMBNESS AND TINGLING IN THE RIGHT ARM AND HAND WITH WEAKNESS AND DECREASED GRIP STRENGTH. EMG STUDIES WERE COMPATIBLE WITH CARPAL TUNNEL SYNDROME. BY FOLLOW-UP ON (B)(6) 2006, THE PATIENT WAS NOT TO HAVE NUMBNESS AND TINGLING OVER THE LATERAL DIGITS OF THE LEFT FOOT. CARPAL TUNNEL RELEASE WAS PERFORMED WITH RESOLUTION OF THE NUMBNESS AND TINGLING. AT FOLLOW UP ON (B)(6) 2007, THE PATIENT'S WRIST PAIN CONTINUED AND IT WAS NOTED THAT HE HAD BEEN HAVING NUMBNESS AND TINGLING IN THE TOES OF THE LEFT FOOT. FOLLOW UP INFORMATION WAS RECEIVED ON 13 JULY 2011 VIA MEDICAL RECORDS. ON (B)(6) 2006, THE PATIENT WAS EVALUATED FOR BILATERAL HAND NUMBNESS AND TINGLING, RIGHT GREATER THAN LEFT, FOR APPROXIMATELY ONE YEAR (2005). THE PATIENT ALSO REPORTED HAVING NUMBNESS AND TINGLING IN THE LEFT FOOT. NERVE CONDUCTION STUDIES WERE NOTABLE FOR SIGNIFICANT RIGHT MEDIAN NEUROPATHY AT THE WRIST, WITH NO EVIDENCE OF RADICULOPATHY. THE PATIENT WAS DIAGNOSED WITH CARPAL TUNNEL SYNDROME AND SCHEDULED FOR CARPAL TUNNEL SYNDROME HAD CLEARED POSTOPERATIVELY. ACCORDING TO NERVE CONDUCTION STUDIES, THERE WAS EVIDENCE OF A MILD PERIPHERAL POLYNEUROPATHY. ON (B)(6) 2010, THE PATIENT WAS SEEN IN FOLLOW UP FOR ASSESSMENT OF LYRICA THERAPY FOR TREATMENT OF DIABETIC NEUROPATHY. THE PATIENT REPORTED HIS SYMPTOMS HAD IMPROVED SIGNIFICANTLY WITH SIGNIFICANTLY LESS BURNING. THIS CASE HAS BEEN UPGRADED TO MEDICALLY SERIOUS BY GSK.

    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