BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE

    MDR report key: 1651973 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00037
    Event Type
    Other
    Date Received
    April 5, 2010
    Date of Event
    January 1, 2008
    Report Date
    September 2, 2009
    Manufacturer
    PROCTER & GAMBLE CO.
    Product Code
    KOO
    PMA / PMN Number
    945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED. THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. JOURNAL: NEUROTOXICOLOGY. AUTHOR: PETER HEDERA, AMANDA PELTIER, JOHN K. FINK, SANDY WILCOCK, ZACHARY LONDON, GEORGE J. BREWER. TITLE: MYELOPOLYNEUROPATHY AND PANCYTOPENIA DUE TO COPPER DEFICIENCY AND HIGH ZINC LEVELS OF UNK ORIGIN II. THE DENTURE CREAM IS A PRIMARY SOURCE OF EXCESSIVE ZINC. VOLUME: 30, YEAR: 2009, PAGES: 996-999.

    Description of Event or Problem · 1

    DEMYELINIZATION POLYNEUROPATHY [DEMYELINATING POLYNEUROPATHY], MYELOPATHY [MYELOPATHY], AXONAL POLYNEUROPATHY [PERIPHERAL SENSORY NEUROPATHY], HYPOCUPREMIA/COPPER DEFICIENCY [COPPER DEFICIENCY], HYPERZINCEMIA [HYPERZINCEMIA], NUMBNESS OF UPPER AND LOWER EXTREMITIES [HYPOAESTHESIA], PARESTHESIA OF UPPER AND LOWER EXTREMITIES [PARESTHESIA], LOSS OF BALANCE [BALANCE DISORDER], NEUROLOGICAL EXAM-DEFICITS INVOLVING MOTOR-SENSORY POLYNEUROPATHY & MYELOPATHY [NEUROLOGICAL EXAMINATION ABNORMAL], BONE MARROW SUPPRESSION [BONE MARROW FAILURE], ANEMIA [ANAEMIA], DISTAL WEAKNESS 2/5 [MUSCULAR WEAKNESS], PLASMA COPPER DECREASED [BLOOD COPPER DECREASED], PLASMA ZINC INCREASED [BLOOD ZINC INCREASED], URINE COPPER DECREASED [URINE COPPER DECREASED], URINE ZINC INCREASED [URINE ANALYSIS]. AN ARTICLE IN A NEUROTOXICOLOGY PUBLICATION REPORTED THAT AN ADULT MALE USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND POLI-GRIP DENTURE ADHESIVE, VERSION UNK CREAM, APPLYING LARGE AMOUNTS ON POORLY FITTING DENTURES, OFTEN USING DENTURES OVERNIGHT, AND REPORTED THE FOLLOWING (B)(6) IN 2008 AT THE AGE OF (B)(6): MYELOPATHY, AXONAL POLYNEUROPATHY, DEMYELINIZATION POLYNEUROPATHY, HYPOCUPREMIA/COPPER DEFICIENCY, HYPERZINCEMIA, NUMBNESS OF UPPER AND LOWER EXTREMITIES, PARESTHESIA OF UPPER AND LOWER EXTREMITIES, LOSS OF BALANCE, NEUROLOGICAL EXAM-DEFICITS INVOLVING MOTOR-SENSORY POLYNEUROPATHY AND MYELOPATHY, BONE MARROW SUPPRESSION, ANEMIA, DISTAL WEAKNESS 2/5, PLASMA COPPER DECREASED, PLASMA ZINC INCREASED, URINE COPPER DECREASED, AND URINE ZINC INCREASED. THE CONSUMER DISCONTINUED USE OF FIXODENT AND POLI-GRIP. TREATMENT: ORAL COPPER SUPPLEMENTATION WITH A TYPICAL DOSE OF 6 MG OF COPPER PER DAY. NEUROIMAGING STUDIES ENCOMPASSING WHOLE NEUROAXIS WERE UNREMARKABLE. INITIAL COPPER PLASMA LEVEL WAS DEPRESSED AT 5 UGH/DL AND AN INITIAL ZINC LEVEL WAS ELEVATED AT 132 UG/DL. INITIAL COPPER URINE LEVEL DEPRESSED WAS 10 UG/DAY, INITIAL ZINC WAS ELEVATED AT 1,250 UG/DAY. HIGHEST PLASMA COPPER LEVEL ON SUPPLEMENTATION SHOW THE LEVEL HAD INCREASED FROM THE INITIAL LEVEL; HOWEVER, WAS STILL WITHIN THE DEPRESSED RANGE AT 41 UG/DL, ZINC PLASMA SHOWED PERSISTENT HYPERZINCEMIA. COPPER PLASMA LEVEL AFTER CESSATION OF DENTURE CREAM USE WAS WITHIN THE NORMAL RANGE AT 85 UG/DL AND ZINC PLASMA LEVELS WERE WITHIN NORMAL LIMITS AT 112 UG/DL. COPPER URINE LEVEL AFTER CESSATION OF DENTURE CREAM WAS WITHIN NORMAL LIMITS AT 27 UG/DAY AND ZINC HAD DECREASED ALTHOUGH STILL ELEVATED AT 1,210 UG/DAY. HYPOCUPREMIA, PLASMA COPPER DECREASED, AND URINE COPPER DECREASED WERE RECOVERED. NEUROLOGIC OUTCOME WAS NO CHANGED AND THE CONSUMER CONTINUED WALKING WITH SUPPORT OF A WALKER. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY -DENTURE WEARER FOR 15 YEARS. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE NONE KOO PROCTER & GAMBLE CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R| S