BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU

    MDR report key: 1622874 · Received March 3, 2010

    Report

    Report Number
    1530449-2010-00004
    Event Type
    Other
    Date Received
    March 3, 2010
    Report Date
    February 19, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER, THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. PMA/501(K) # 945200.

    Description of Event or Problem · 1

    NEUROPATHY (PROVISION DX) [NEUROPATHY PERIPHERAL]. PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NEUROLOGICAL COMPLICATION FROM DEVICE]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. EXCESS ZINC [HYPERZINCAEMIA]. COPPER DEPLETION [COPPER DEFICIENCY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, AND ADULT FEMALE AGE (B)(6), USED (AND INGESTED) FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM ON DENTURES SHE REC'D OVER 20 YEARS AGO AND HAS SUFFERED FROM PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, AND WAS DIAGNOSED WITH NEUROPATHY ATTRIBUTED TO EXCESS ZINC AND RESULTING COPPER DEPLETION. SHE DISCONTINUED USE OF FIXODENT AFTER BEING DIAGNOSED WITH NEUROPATHY. SHE HAS REC'D AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. BECAUSE OF THE EVENTS, THE CLIENT HAD DISABILITIES AND WAS UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG CO

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability