BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1651970 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00039
    Event Type
    Other
    Date Received
    April 5, 2010
    Date of Event
    January 1, 2002
    Report Date
    September 2, 2009
    Manufacturer
    PROCTER & GAMBLE MFG CO.
    Product Code
    KOO
    PMA / PMN Number
    (US) OTC DEV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT NOT PROVIDED THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. PMA/510(K)#K945200. REPORT SOURCE LITERATURE DESCRIPTION. 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

    PANCYTOPENIA [PANCYTOPENIA]. MYELOPATHY [MYELOPATHY]. DEMYELINIZATION POLYNEUROPATHY [DEMYELINATING POLYNEUROPATHY]. AXONAL POLYNEUROPATHY [PERIPHERAL SENSORY NEUROPATHY]. HYPOCUPREMIA / COPPER DEFICIENCY [COPPER DEFICIENCY]. HYPERZINCEMIA [HYPERZINCAEMIA]. NUMBNESS OF UPPER AND LOWER EXTREMITIES [HYPOAESTHESIA]. PARESTHESIA OF UPPER AND LOWER EXTREMITIES [PARAESTHESIA]. LOSS OF BALANCE [BALANCE DISORDER]. NEUROLOGICAL EXAM-DEFICITS INVOLVING MOTOR-SENSORY POLYNEUROPATHY & MYELOPATHY [NEUROLOGICAL EXAMINATION ABNORMAL]. BONE MARROW SUPPRESSION [BONE MARROW FAILURE]. DISTAL WEAKNESS 3/5 [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 BEGINNING IN 2002 AT THE AGE OF (B)(6): MYELOPATHY, DEMYELINIZATION POLYNEUROPATHY, AXONAL 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, PANCYTOPENIA, DISTAL WEAKNESS 3/5, PLASMA COPPER DECREASED, PLASMA ZINC INCREASED, URINE COPPER DECREASED, AND URINE ZINC INCREASED. THE CONSUMER DISCONTINUED USE OF FIXODENT AND POLI-GRIP. TREATMENT: ORAL SUPPLEMENTATION WITH A TYPICAL DOSE OF 6MG OF COPPER PER DAY. NEUROIMAGING STUDIES ENCOMPASSING WHOLE NEUROAXIS WERE UNREMARKABLE. INITIAL COPPER PLASMA LEVEL WAS DEPRESSED AT 5UG/DL, INITIAL ZINC LEVEL WAS ELEVATED AT 198 UG/DL. INITIAL COPPER URINE LEVEL WAS DEPRESSED AT 3UG/DAY, INITIAL ZINC URINE LEVEL WAS ELEVATED AT 2,120 UG/DAY. HIGHEST COPPER PLASMA LEVEL ON SUPPLEMENTATION WAS WITHIN NORMAL LIMITS AT 75UG/DL, ZINC PLASMA LEVEL SHOWED PERSISTENT HYPERZINCEMIA. COPPER PLASMA LEVEL AFTER CESSATION OF DENTURE CREAM WAS WITHIN NORMAL LIMITS AT 103UG/DL, ZINC PLASMA LEVEL WAS WITHIN NORMAL LIMITS AT 87UG/DL. COPPER URINE LEVEL AFTER CESSATION OF DENTURE CREAM WAS WITHIN NORMAL LIMITS AT 22UG/DAY, ZINC URINE LEVEL HAD DECREASED ALTHOUGH STILL ELEVATED AT 980UG/DAY. PLASMA COPPER DECREASED, PLASMA ZINC INCREASED, AND URINE COPPER DECREASED WERE RECOVERED. THE NEUROLOGIC OUTCOME SHOWED IMPROVEMENT AND THE CUSTOMER WENT FROM USING A WHEELCHAIR TO WALKING WITH A WALKER. THE CASE OUTCOME WAS IMPROVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER FOR 25 YRS. 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 MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R| S