BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 1981208 · Received January 28, 2011

    Report

    Report Number
    9681138-2011-00024
    Event Type
    Other
    Date Received
    January 28, 2011
    Report Date
    January 27, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 COPPER DEFICIENCY IN A FEMALE PT WHO USED POLIGRIP (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT USED POLIGRIP AT UNK DOSING. AT AN UNK TIME AFTER USING POLIGRIP, THE PT EXPERIENCED COPPER DEFICIENCY, ZINC POISONING, AND NERVE INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. ACCORDING TO A LEGAL CLAIM, THERE WERE 26 PTS WHO REPORTED BEING REGULAR USERS OF ZINC-CONTAINING POLIGRIP OR A COMBINATION OF ZINC-CONTAINING POLIGRIP AND FIXODENT. ALL OF THE PTS EXPERIENCED "NEUROLOGICAL MANIFESTATIONS OF ZINC-INDUCED COPPER DEFICIENCY." THE ATTORNEYS BELIEVED THAT THEIR "CLIENTS' USE OF POLIGRIP WAS THE SUBSTANTIAL AND PROBABLE CAUSE OF THEIR INJURIES." F/U INFO WAS RECEIVED ON (B)(4) 2010, VIA MEDICAL RECORDS. ON (B)(6) 2007, THE PT HAD A PROBABLE NON-DISPLACED FRACTURE OF THE DISTAL SACRUM/COCCYGEAL REGION, WHERE DIFFUSE MARROW EDEMA WAS PRESENT. PHYSIOTHERAPY NOTES FROM (B)(6) 2007 UNTIL (B)(6) 2007 REPORTED IMPROVEMENT IN THE PT FROM THE POINT OF HAVING PANIC ATTACKS TO BEING ABLE TO RELAX AND PERFORM AN EXERCISE ROUTINE. THE PT WAS STRONGER IN HER LEGS AND BACK, BUT HER MAIN PROBLEM WAS BALANCE AND COORDINATION. ON (B)(6) 2008, THE PT COMPLAINED OF PARESTHESIAS IN THE LOWER EXTREMITIES AND GAIT ATAXIA. HER SYMPTOMS BEGAN AFTER A FALL AT WORK. A MAGNETIC RESONANCE IMAGING OF THE CERVICAL SPINE PERFORMED ON (B)(6) 2007, SHOWED A STRAIGHTENING OF THE CERVICAL LORDOSIS, WITH DIMINISHED DISC SIGNAL AND POSTERIOR SHALLOW MIXED SPONDYLITIC PROTRUSION. THERE WAS BILATERAL UNCOVERTEBRAL JOINT DEGENERATIVE CHANGE AT C5/6 CAUSING MILD MIDLINE, BILATERAL RECESS AND FORAMINAL ENCROACHMENT. ELECTROMYOGRAPH/NERVE CONDUCTION STUDIES PERFORMED ON (B)(6) 2007, WERE NORMAL. ON (B)(6) 2008, ELECTROMYOGRAPHY/NERVE CONDUCTION STUDIES COULD NOT RULE OUT BILATERAL S1 RADICULOPATHY. ON (B)(6) 2008, THE PT WAS SEEN IN (B)(6) FOR F/U. SYMPTOMS WERE UNCHANGED. SHE STILL HAD DIFFICULTY WITH COORDINATION, NUMBNESS/TINGLING IN THE BILATERAL LEGS TO THE FEET, AND PAIN. ON (B)(6) 2008, THE PT COMPLAINED OF LOW BACK AND BILATERAL RADICULAR LEG PAIN RADIATING TO THE FEET WITH ASSOCIATED NUMBNESS AND ABNORMAL GAIT. THE PT UNDERWENT A (B)(4) STUDY ((B)(4)), THAT SHOWED POSSIBLE BILATERAL S1 RADICULOPATHIES. THE PT HAD A FALL ON (B)(6) 2007, WHEN SHE FELL FROM AN OFFICE STOOL AND STRUCK HER BUTTOCKS AND HEAD AGAINST THE FURNITURE. THE PT HAD PARTICIPATED IN AQUATIC THERAPY WHICH HAD HELPED TO ALLEVIATE THE PAIN. THE PT WAS ALSO TREATED WITH LYRICA. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE BRAIN ON (B)(6) 2007, SHOWED AN INCIDENTAL RIGHT PARIETAL SKULL OSTEOMA. MAGNETIC RESONANCE IMAGINGS (MRI) OF THE THORACIC AND LUMBAR SPINE WERE NORMAL. THE PT ALSO RECEIVED PHYSICAL THERAPY. THE PT HAD A "HYSTERICAL GAIT". MEDICAL RECORDS RECEIVED ON (B)(6) 2011: THE PT WAS EVALUATED BY A NEUROLOGIST FOR LEFT HAND WEAKNESS AND NUMBNESS AS EARLY AS (B)(6) 2006. SHE STATED, IT FELT AS IF HER HAND HAD "GONE TO SLEEP" OVER THE SEVERAL WEEKS PRIOR AND HAD PROGRESSED TO THE POINT THAT SHE WAS LOSING STRENGTH IN HER LEFT HAND. THIS PAIN AND NUMBNESS WENT UP INTO THE ARM AND SHOULDER, AND SHE WAS BEGINNING TO HAVE SOME DISCOMFORT AND NUMBNESS IN THE TIP OF HER RIGHT FINGER. AT A PHYSICIAN VISIT ON (B)(6) 2009, IT WAS NOTED, THE PT HAD BEEN DIAGNOSED WITH ABNORMAL GAIT PROBLEM DUE TO COMPLETE NUMBNESS FROM THE WAIST DOWN. AT A VISIT ON (B)(6) 2009, THE PT WAS NOTED TO HAVE A HIGH ZINC LEVEL WITH THE PT THOUGHT WAS FROM HER DENTURES. AT A VISIT ON (B)(6) 2010, THE PT STATED, SHE CONTINUED TO WEAR THE DENTURE WHICH SHE CLAIMED HAD ZINC IN IT AND NOTED TO BE LOSING HER BALANCE AND HAVING NUMBNESS. SHE WAS FOLLOWED UP FOR "ZINC POISONING DUE TO DENTURE ADHESIVE" ON (B)(6) 2010. BY (B)(6) 2010, THE PT WAS NOTED TO BE USING A ZINC-FREE DENTURE ADHESIVE WITH CONTINUED NEUROPATHY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability