BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1694426 · Received May 12, 2010

    Report

    Report Number
    1530449-2010-00073
    Event Type
    Other
    Date Received
    May 12, 2010
    Report Date
    May 4, 2010
    Manufacturer
    PROCTER & GAMBLE MFG CO.
    Product Code
    KOO
    PMA / PMN Number
    K9452000
    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, THERFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. OTC PRDUCT: YES.

    Description of Event or Problem · 1

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. PROFOUND AND PERMANENT INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. HYPERZINCEMIA [HYPERZINCAEMIA]. HYPOCUPREMIA [COPPER DEFICIENCY]. NEUROPATHY [NEUROPATHY PERIPHERAL]. PHYSICAL PAIN [PAIN]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HIS CLIENT, AN ADULT FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE CREAM AND SUPER POLIGRIP DENTURE ADHESIVE CREAM, UNSPECIFIED TOTAL DAILY USE ON DENTURES SHE RECEIVED IN 1990, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, HYPERZINCEMIA, HYPOCUPREMIA, NEUROPATHY, PHYSICAL PAIN, AND PROFOUND AND PERMANENT INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES THAT HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES. 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 DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability