BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2170162 · Received June 27, 2011

    Report

    Report Number
    9681138-2011-00155
    Event Type
    Other
    Date Received
    June 27, 2011
    Report Date
    June 24, 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

    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 VIA A AGREEMENT, AND DESCRIBED THE OCCURRENCE OF AN UNSPECIFIED INJURY IN A FEMALE PATIENT WHO USED POLIGRIP (FORMULATION UNKNOWN) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIGRIP. AT AN UNKNOWN TIME AFTER STARTING POLIGRIP, THE PATIENT EXPERIENCED AN UNSPECIFIED INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED VIA MEDICAL RECORDS ON (B)(6) 2009. ON (B)(6) 2009, THE (B)(6) PATIENT EXPERIENCED A HIGH ZINC LEVEL AND A LOW COPPER LEVEL. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED VIA A (B)(4) AGREEMENT ON (B)(6) 2010. THE PATIENT EXPERIENCED NEUROLOGICAL INJURIES DUE TO THE INGESTION OF POLIGRIP. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2011 VIA MEDICAL RECORDS. ON (B)(6) 2009, THE PATIENT WAS SEEN IN FOLLOW UP OF ANEMIA AND VITAMIN B12 DEFICIENCY. THE PATIENT HAD B12 DEFICIENCY ANEMIA WITH NEGATIVE INTRINSIC FACTOR AB, NEGATIVE PARIETAL CELL AB, AND NO HISTORY OF GASTRIC SURGERY. ASSESSMENT INCLUDED PANCYTOPENIA AND NEUROPATHY. ON (B)(6) 2009, THE PATIENT REPORTED HER NEUROPATHY WAS GETTING WORSE. ASSESSMENT ALSO INCLUDED COPPER DEFICIENCY AND ZINC TOXICITY. THE PATIENT'S COPPER LEVEL WAS ONLY 6 AND ZINC LEVEL WAS ELEVATED AT 303. THERE WAS A SUSPICION THAT THE ABNORMALITIES WERE DUE TO THE DENTURE CREAM THAT THE PATIENT USED. COPPER 2 MG DAILY WAS STARTED AND THE PATIENT WAS ADVISED TO "HOLD OFF" THE DENTURE CREAM. ON (B)(6) 2009, THE PATIENT STILL HAD A LOT OF TINGLING, NUMBNESS, AND LOSS OF BALANCE. THE PATIENT'S COMPLETE BLOOD COUNT (CBC) WAS NORMAL. ON (B)(6) 2010, THE PATIENT HAD BEEN IN A CAR WRECK, BROKE HER COLLARBONE, AND LOST A TOOTH. THE PATIENT COULD NOT PICK THINGS UP, WAS NOT DRIVING, AND COULD NOT HOLD HER GRANDCHILD UP. THE PATIENT CONTINUED ON IRON PILLS, B12 LIQUID, ORAL COPPER, AND FOLIC ACID. THIS CASE HAS BEEN UPGRADED TO MEDICALLY SERIOUS BY GSK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other