BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP/POLIGRIP (FORMULATION UNKNOWN)

    MDR report key: 1943797 · Received December 17, 2010

    Report

    Report Number
    9681138-2010-00413
    Event Type
    Other
    Date Received
    December 17, 2010
    Report Date
    December 17, 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

    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 COMPLAINT AND DESCRIBED THE OCCURRENCE OF ZINC TOXICITY IN A FEMALE PT WHO USED SUPER POLIGRIP (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. IN 1992, THE PT USED SUPER POLIGRIP AT UNK DOSING. AT AN UNK TIME AFTER USING SUPER POLIGRIP, THE PT EXPERIENCED ZINC TOXICITY, COPPER DEFICIENCY, EXTENSIVE NERVE DAMAGE RESULTING IN LOSS OF BALANCE, PAIN, SEVERE CRAMPING, LOSS OF STRENGTH IN BOTH LEGS, ATAXIA, HYPERREFLEXIA, AND NEUROLOGICAL INJURIES. ACCORDING TO THE LEGAL COMPLAINT, THE PT SUFFERED SEVERE AND PERMANENT PHYSICAL INJURIES, INCLUDING BUT NOT LIMITED TO PROFOUND AND PERMANENT NEUROLOGICAL INJURIES. THE DAMAGES ARE PERMANENT AND WILL CONTINUE INTO THE FUTURE. AT THE TIME OF REPORTING, THE EVENTS ARE UNRESOLVED. F/U INFO WAS RECEIVED ON 8/3/2010 VIA MEDICAL RECORDS. ON (B)(6) 2002, ELECTRODIAGNOSTIC STUDIES OF THE RIGHT LOWER EXTREMITY WERE CONSISTENT WITH A MILD TO MODERATE ACUTE AXONAL L5/S1 RADICULOPATHY AND NO EVIDENCE OF A PERIPHERAL NEUROPATHY. ON (B)(6) 2002, THE PT HAD UNDERGONE PHYSICAL THERAPY, EPIDURAL INJECTIONS, AND RECENTLY HAD A MYELOGRAM COMPUTED TOMOGRAPHY (CT). ON (B)(6) 2002, IT WAS NOTED THE PT COMPLAINED OF TIGHTNESS AND PARESTHESIAS OF PINS AND NEEDLES ON THE RIGHT AND LEFT, AND MOSTLY FROM THE KNEES DOWN AND DIFFICULTY BALANCING AND WALKING THAT STARTED IN (B)(6) 2001. THE PT HAD DIFFICULTY WITH BOWEL AND BLADDER. ELECTROMYOGRAPHY (EMG) AND NERVE CONDUCTION STUDIES (NCS) SHOWED ELECTROPHYSIOLOGIC EVIDENCE OF POSSIBLY BILATERAL L5 TO S1 CHRONIC RADICULOPATHY. ON (B)(6) 2004, THE PT HAD COMPLETED A MAGNETIC RESONANCE IMAGING (MRI) OF HER CERVICAL SPINE WHICH JUST SHOWED DISCOGENIC DISEASE AND HYPERTROPHIC ARTHROSIS AND BORDERLINE CANAL WITH SLIGHT BILATERAL FORAMINAL STENOSIS AT C4/5. THE SPINAL CORD AND CERVICAL MEDULLARY JUNCTION WERE WITHIN NORMAL LIMITS. ON (B)(6) 2005, THE PT HAD COMPLETED A MYELOGRAM AND SURGERY WITH DECOMPRESSION AND FUSION OF C4/5 WAS RECOMMENDED. IMPRESSION INCLUDED GAIT DISORDER, SPASMS AND CRAMPS, AND LOWER EXTREMITY WEAKNESS WHICH WAS MOST LIKELY A COMBINATION OF CERVICAL SPINE DISEASE AND LUMBOSACRAL RADICULOPATHY. ON (B)(6) 2007, THE PT WANTED AN ALTERNATIVE FOR NEURONTIN. SHE DID NOT FEEL IT WAS EFFECTIVE AND MIGHT BE MAKING HER SOMEWHAT FATIGUED. SHE STILL HAD LOWER EXTREMITY PAIN, DIFFICULTY WITH GAIT, AND WORE A BRACE ON HER RIGHT LEG. TREATMENT INCLUDED NEURONTIN AND VICODIN. THE RECOMMENDATION WAS FOR THE PT TO SWITCH TO CYMBALTA AND WEAN OFF NEURONTIN. ON (B)(6) 2007, THE PT REPORTED CYMBALTA AND NEURONTIN WERE EFFECTIVE TOGETHER. ON (B)(6) 2010, A COPPER LEVEL WAS 98 (NORMAL 70 TO 175 MC/DL) AND A ZINC LEVEL WAS 187 (NORMAL 60 TO 130 MCG/DL). ON (B)(6) 2010, THE PT RECENTLY HAD AN ELEVATED ZINC LEVEL. SHE HAD A TOXICOLOGY CONSULT AND IT WAS THOUGHT THIS WAS FROM POLIGRIP. THE PT DISCONTINUED USE OF POLIGRIP IN (B)(6) 2010 AFTER READING AN ARTICLE ABOUT WEAKNESS AND NUMBNESS. IMPRESSION INCLUDED CERVICAL SPINE INJURIES AND CHRONIC PAIN, AS WELL AS PREVIOUS LUMBOSACRAL RADICULOPATHY. F/U INFO WAS RECEIVED ON (B)(4) 2010 VIA MEDICAL RECORDS. ON (B)(6) 2007, IT WAS REPORTED THE PT FELL AS HER LEFT LEG GAVE OUT. SHE HAD SINCE RECOVERED. ON (B)(6) 2007, THE PT PREFERRED A SINGLE POINT CANE OVER THE QUAD CANE. ON (B)(6) 2009, A BONE MINERAL DENSITY TEST WAS DIAGNOSTIC OF OSTEOPENIA. ON (B)(6) 2010, THE PT REQUESTED LAB WORK TO BE DRAWN FOR CONCERN REGARDING HER LONG TIME USE OF POLIGRIP (FORMULATION UNK). IT WAS REPORTED THAT POLIGRIP HAD RECENTLY BEEN TAKEN OFF THE SHELF FOR HAVING ZINC IN IT. F/U INFO WAS RECEIVED ON (B)(4) 2010 VIA MEDICAL RECORDS. ON (B)(6) 2002, THE PT WAS EVALUATED WITH COMPLAINTS OF HAVING A HISTORY OF INCREASING GAIT DIFFICULTY SINCE (B)(6) 2001. THE PT HAD DIFFICULTY WITH BALANCE AND PAIN AND TIGHTNESS IN THE RIGHT KNEE REGION. THE PT WAS HOSPITALIZED FROM (B)(6) 2002 WITH LUMBAR SPINAL STENOSIS AND SCOLIOSIS WITH LUMBAR DECOMPRESSIVE LAMINECTOMY OF L3/4, L4/5, AND L5/S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP/POLIGRIP (FORMULATION UNKNOWN) DENTURE ADHESIVE CREAMS KOL GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization