BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1651938 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00013
    Event Type
    Other
    Date Received
    April 5, 2010
    Report Date
    March 16, 2009
    Manufacturer
    PROCTER & GAMBLE CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    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 BY THE REPORTER; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    NEUROPATHY [NEUROPATHY PERIPHERAL], PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER], OTHER SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY], EXCESS ZINC [BLOOD ZINC INCREASED], COPPER DEPLETION [COPPER DEFICIENCY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, A MALE, AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND SUPER POLIGRIP FOR DENTURE ADHESIVE PURPOSES FOR APPROX 29 YEARS AND REPORTED THAT HIS CLIENT WAS DIAGNOSED WITH NEUROPATHY; HAS PROFOUND AND PERMANENT NEUROLOGICAL INJURIES; OTHER SEVERE AND PERMANENT PHYSICAL INJURIES WHICH HAVE LEFT HIM UNABLE TO PERFORM HIS NORMAL, CUSTOMARY AND DAILY ACTIVITIES; EXCESS ZINC; AND COPPER DEPLETION. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY-DENTURE WEARER. 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 71 YR Disability