BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (ORIG/FREE/UNK), POLIDENT

    MDR report key: 2093983 · Received April 27, 2011

    Report

    Report Number
    9681138-2011-00097
    Event Type
    Other
    Date Received
    April 27, 2011
    Report Date
    April 26, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    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 NERVE DAMAGE 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 ((B)(4)) AND FIXODENT. IN 1995, THE PATIENT USED SUPER POLIGRIP AS A DENTURE ADHESIVE AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING SUPER POLIGRIP, THE PATIENT EXPERIENCED NERVE DAMAGE, ZINC TOXICITY, WALKING INSTABILITY, UNSTEADY ON STANDING, TINGLING, NUMBNESS, BURNING SENSATION, LEG AND FEET PAIN, AND WEAKNESS OF FOOT AND LEG. 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 UNSTEADY WALKING OR STANDING, TINGLING, NUMBNESS, BURNING, PAIN AND WEAKNESS IN FEET AND LEGS." 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." FOLLOW UP INFORMATION WAS RECEIVED ON (B)(4) 2011, VIA FACT SHEETS SUBMITTED BY THE PATIENT'S ATTORNEY. ACCORDING TO THE FACT SHEETS, THE PATIENT'S FIRST USE OF DENTURES WAS IN APPROXIMATELY 1994. THE PATIENT REPORTED WEARING PARTIAL UPPER AND LOWER DENTURES FROM APPROXIMATELY 1994 UNTIL (B)(6) 2010. THE PATIENT WORE FULL UPPER AND LOWER DENTURES FROM (B)(6) 2010 UNTIL THE TIME OF THIS REPORT. THE PATIENT USED SUPER POLIGRIP ORIGINAL (1995 UNTIL 2010), SUPER POLIGRIP FREE ((B)(4)) (2011 TO THE TIME OF THIS REPORT), AND FIXODENT FROM 1995 UNTIL THE TIME OF THIS REPORT. THE PATIENT USED SUPER POLIGRIP ORIGINAL AND SUPER POLIGRIP FREE SEVEN TIMES PER WEEK, ONCE A DAY TO UPPER AND LOWER DENTURES. THE PATIENT SOAKED HIS DENTURES IN POLIDENT CLEANER (FORMULATION UNKNOWN) EVERY NIGHT. THE PT NORMALLY USED FIXODENT ORIGINAL (1995 TO 2010), BUT USED OTHER FORMULATIONS OF FIXODENT WHEN FIXODENT ORIGINAL WAS NOT AVAILABLE IN STORES. THE PATIENT CURRENTLY USED FIXODENT FREE. THE PATIENT HAD BEEN PREVIOUSLY DIAGNOSED WITH HYPERZINCEMIA (SYMPTOMS BEGAN IN 2007 AND DIAGNOSED IN 2010), SCIATICA (SYMPTOMS BEGAN IN 2006 AND DIAGNOSED IN 2007), AND NEUROPATHY (SYMPTOMS BEGAN IN 2007 AND DIAGNOSED IN 2010). THE PATIENT ALSO REPORTED HAVING "PAIN IN THE NECK, RIGHT HIP AND LEFT SHOULDER." THE PATIENT HAD A ZINC LEVEL OF 146 (NORMAL 60 TO 130) AND COPPER LEVEL OF 99 (NORMAL 70 TO 175). THIS CASE HAS BEEN UPGRADED TO MEDICALLY SERIOUS BY GSK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (ORIG/FREE/UNK), POLIDENT DENTURE ADHESIVE CREAM/CLEANSER KOL GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FIXODENT