BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1696220 · Received May 19, 2010

    Report

    Report Number
    1530449-2010-00078
    Event Type
    Other
    Date Received
    May 19, 2010
    Report Date
    May 12, 2010
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    (US) OTC DEV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. PMA/510(K) # 945200.

    Description of Event or Problem · 1

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. PROFOUND AND PERMANENT INJURIES [INJURY]. EXCESS ZINC [BLOOD ZINC INCREASED]. COPPER DEPLETION [BLOOD COPPER DECREASED]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HIS CLIENT, AN ADULT FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE , VERSION UNK CREAM AND SUPER POLIGRIP CREAM BEGINNING 1992, WHEN SHE BECAME DENTURE DEPENDENT, THROUGH 2009 AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, PROFOUND AND PERMANENT INJURIES THAT HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES, AND EXCESS ZINC AND COPPER DEPLETION (B)(6) 2009. TREATMENT: CONSUMER IS IN NEED OF CONSTANT (UNSPECIFIED) CARE AND ASSISTANCE. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY. INCLUDED: MEDICAL HISTORY DENTURE WEARER SINCE 1992. 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% CELLUL DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability