BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 1914390 · Received November 18, 2010

    Report

    Report Number
    9681138-2010-00394
    Event Type
    Other
    Date Received
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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 PATIENTS WHO REPORTED BEING REGULAR USERS OF ZINC-CONTAINING POLIGRIP OR A COMBINATION OF ZINC-CONTAINING POLIGRIP AND FIXODENT. ALL OF THE PATIENTS EXPERIENCED "NEUROLOGICAL MANIFESTATIONS OF ZINC-INDUCED COPPER DEFICIENCY." THE ATTORNEYS BELIEVED THAT THEIR "CLIENTS' USE OF POLIGRIP WAS THE SUBSTANTIAL AND PROVABLE CAUSE OF THEIR INJURIES." MEDICAL RECORDS RECEIVED (B)(6) 2010: ON (B)(6) 2009, THE PT WAS SEEN FOR NUMBNESS AND TINGLING IN ALL UPPER AND LOWER EXTREMITIES THAT HAD A GRADUAL ONSET ABOUT ONE YEAR PRIOR. THIS WAS WORSENING AND THE PT ALSO HAD WEAKNESS AND IMBALANCE OF GAIT. SHE HAD RECEIVED B12 INJECTIONS AND FAILED VICODIN AND LYRICA. IT WAS FELT THE PT'S PARESTHESIAS WERE DUE TO PERIPHERAL NEUROPATHY AND BEGUN ON NEURONTIN. AT A NEUROLOGY VISIT ON (B)(6) 2009, THE PT'S SYMPTOMS CONTINUED AND IT WAS NOTED THAT SHE HAD USED POLIGRIP FOR FOUR YEARS AT THREE TO FOUR APPLICATIONS ON THE BOTTOM. THE NEUROLOGIST LISTED SUSPECTED POLIGRIP TOXICITY AS A CAUSE OF THE SYMPTOMS. BY FOLLOW UP ON (B)(6) 2009, THE PT HAD SWITCHED FROM POLIGRIP TO FIXODENT AND IT WAS NOTED THAT THE CAUSE WAS SUSPECTED ZINC TOXICITY WITH COPPER DEFICIENCY. AT FOLLOW UP ON (B)(6) 2009, THE PT HAD STOPPED USE OF ZINC DENTAL ADHESIVES WITH SOME IMPROVEMENT IN BALANCE. COPPER SUPPLEMENTATION WAS STARTED AT THAT TIME. AT FOLLOW UP ON (B)(6) 2009, THE PT'S DENTURES HAD BEEN REFITTED AND SHE WAS USING A SMALL AMOUNT OF POLIGRIP ON THE LOWER DENTURE ONCE DAILY. SHE HAD PREVIOUSLY USED THIS SEVERAL TIMES A DAY AND USED TO SWALLOW SOME OF THE PRODUCT. SYMPTOMS PERSISTED AT FOLLOW UP ON (B)(6) 2010, AND THE PT CONTINUED ON COPPER SUPPLEMENTATION. COPPER SUPPLEMENTATION WAS STOPPED AT FOLLOW UP ON (B)(6) 2010. FOLLOW UP INFO WAS RECEIVED ON (B)(6) 2010 VIA MEDICAL RECORDS. ON (B)(6) 2010, IT WAS NOTED THE PT'S CHRONIC PROBLEMS INCLUDED NEUROPATHY AND ZINC POISONING. WORK STATUS INCLUDED DISABILITY DUE TO ZINC POISONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability