BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GSK DENTURE ADHESIVE

    MDR report key: 2805394 · Received October 14, 2009

    Report

    Report Number
    9681138-2009-00197
    Event Type
    Injury
    Date Received
    October 14, 2009
    Date of Event
    January 1, 2009
    Report Date
    October 13, 2009
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S REPORT NUMBER FOR THIS CASE IS 9681138-2009-00153. POLIGRIP IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT, NOR LOT NUMBER FOR THE PRODUCT IS AVAILABLE. ADD'L BRAND NAME AND COMMON DEVICE NAME: CA NA POLY (V-MET-ETH-MAL), LOT # UNK.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A (B)(6) FEMALE PT WHO RECEIVED POLIGRIP (FORMULATION UNK) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. PLAINTIFF GOT DENTURES WHEN SHE WAS APPROX (B)(6). CO-SUSPECT MEDICATION INCLUDED FIXODENT. ON AN UNK DATE, THE PT STARTED POLIGRIP AND FIXODENT (DENTAL). IN 2009, THE PT EXPERIENCED NEUROPATHY, ZINC HIGH, COPPER DEPLETION, NERVE INJURY AND INJURY. THE ATTORNEY STATED "PLAINTIFFS AVER THAT WHEN SUPER POLIGRIP AND FIXODENT ARE FORESEEABLY SWALLOWED AND/OR OTHERWISE EXPOSED TO THE USER'S GASTROINTESTINAL TRACT, ZINC IN EXCESS AMOUNTS IS ABSORBED IN THE BODY'S TISSUES, UPSETTING MINERAL HOMEOSTASIS AND RESULTING IN DEPLETED COPPER LEVELS IN THE BODY. THIS COPPER DEPLETION RESULTS IN THE DEVELOPMENT OF, INTER ALIA, A CONSTELLATION OF NEUROLOGICAL SYMPTOMS GENERALLY REFERRED TO AS NEUROPATHY AND OTHER COMPLICATIONS. BY THE TIME THESE SYMPTOMS ARE NOTICED AND EVENTUALLY CONNECTED TO EXCESS ZINC AND COPPER DEPLETION, PERMANENT NEUROLOGICAL AND OTHER PHYSICAL INJURY HAS ALREADY BEEN SUFFERED BY THE USER.... THE FORMER USER IS THUS LEFT WITH PERMANENT, PROFOUND PERSONAL INJURIES, AND ENDURING DISABILITIES." THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIGRIP AND FIXODENT WAS DISCONTINUED IN 2009 UPON DIAGNOSIS OF NEUROPATHY. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GSK DENTURE ADHESIVE GSK DENTURE ADHESIVE KOL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR