BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1912906 · Received November 11, 2010

    Report

    Report Number
    1530449-2010-00125
    Event Type
    Other
    Date Received
    November 11, 2010
    Report Date
    October 20, 2010
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    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.

    Description of Event or Problem · 1

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. OTHER PHYSICAL INJURIES [INJURY]. DIAGNOSED TO HAVE EXCESS ZINC [BLOOD ZINC INCREASED] COPPER DEPLETION [BLOOD COPPER DECREASED]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HIS (B)(6) MALE CLIENT USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM, SUPER POLIGRIP, AND POLIGRIP, ALL FOR APPROX 10 YEARS BEGINNING IN 2000 WITH LAST KNOWN USE IN 2010, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, OTHER PHYSICAL INJURIES, DIAGNOSED TO HAVE EXCESS ZINC, AND COPPER DEPLETION. TREATMENT: UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL. HISTORY INCLUDED: MEDICAL HISTORY - DENTURE DEPENDENT. 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 MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Disability