BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 1943514 · Received December 2, 2010

    Report

    Report Number
    9681138-2010-00402
    Event Type
    Other
    Date Received
    December 2, 2010
    Report Date
    December 1, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF NERVE DAMAGE IN A FEMALE PT WHO USED POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT BEGAN USING POLIGRIP. ACCORDING TO THE CLAIM, THE PT ALLEGED "PERSONAL INJURIES, INCLUDING NEUROLOGICAL DAMAGES DUE TO HER INGESTION OF POLIGRIP." AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. MEDICAL RECORDS RECEIVED (B)(6) 2010: ON (B)(6) 2009, THE PT WAS SEEN IN THE HOSPITAL DUE TO DIZZINESS AND DIAGNOSED WITH MACROCYTIC ANEMIA AND LOW WHITE COUNT. SHE WAS GIVEN PACKED RED BLOOD CELLS WITH AN INCREASE IN HEMOGLOBIN. BONE MARROW EXAMINATION SHOWED A DECREASE IN THE MYELOID LINE WITH ELEMENTS CONSISTENT WITH IRON AND B12 DEFICIENCY. SHE HAD BEEN TAKING IRON AND WAS STARTED ON B12. SHE HAD A HISTORY OF MODERATE MENTAL RETARDATION, CEREBROVASCULAR ACCIDENT AT AGE (B)(6), AN AUTOMOBILE ACCIDENT RESULTING IN BRAIN SURGERY AT AGE (B)(6) WITH SUBSEQUENT LEFT ARM PARESIS, AND CEREBRAL PALSY. AT FOLLOW UP ON (B)(6) 2010, THE PT CONTINUED ON IRON, AND THE ANEMIA WAS STABLE AND NONPROGRESSIVE. SHE DID NOTE ASSOCIATED FATIGUE SEVERAL TIMES PER WEEK. AT A VISIT ON (B)(6) 2010, THE PT NOTED COLD LEGS WITH DISCOLORATION AND WAS NOTED TO HAVE PANCYTOPENIA. B12, ZINC, AND COPPER LEVELS WERE ORDERED AT THAT TIME DUE TO NEUROLOGICAL CHANGES. COPPER WAS LOW AT 5 MCG/DL (NORMAL 70 TO 155), AND ZINC WAS HIGH AT 172 MCG/DL (NORMAL 70 TO 150) AT THAT TIME. AT A VISIT ON (B)(6) 2010, IT WAS NOTED THAT THE PATIENT'S COURSE WAS PROGRESSIVELY WORSENING, OF MODERATE INTENSITY, AND WITH A FREQUENCY OF SEVERAL TIMES DAILY. ASSOCIATED SYMPTOMS INCLUDED INABILITY TO WALK. PERIPHERAL NEUROPATHY WAS LISTED AS DIAGNOSIS AT THAT TIME. ON (B)(6) 2010, THE PATIENT'S SYMPTOMS CONTINUED AND SHE WAS SENT FOR PHYSICAL THERAPY. IN (B)(6) 2010, COPPER WAS 80 AND ZINC WAS 130. AT NEUROLOGICAL CONSULT ON (B)(6) 2010, THE NEUROLOGIST FELT THE PT HAD SIGNIFICANTLY EXACERBATED PRIOR NEUROLOGICAL INJURY WITH EVIDENCE FOR MYELOPATHY. COPPER DEFICIENCY WAS LISTED AS THE MOST LIKELY CAUSE WITH INCREASED ZINC TAKE AS POSSIBLE CAUSE OF THE COPPER DEFICIENCY. LITTLE PROGRESS WAS NOTED AT FOLLOW UP ON (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization