BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2101183 · Received May 19, 2011

    Report

    Report Number
    1530449-2011-00094
    Event Type
    Other
    Date Received
    May 19, 2011
    Report Date
    May 3, 2011
    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]. EXCESS ZINC [HYPERZINCAEMIA]. COPPER DEPLETION [COPPER DEFICIENCY]. PERMANENT PROFOUND PERSONAL INJURIES AND ENDURING DISABILITIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ELDERLY FEMALE CLIENT, NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM, UNSPECIFIED TOTAL DAILY USE SINCE BECOME DENTURE DEPENDENT THROUGH THE YEAR 2010, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES THAT HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES, PERMANENT PROFOUND PERSONAL INJURIES AND ENDURING DISABILITIES, AND WAS DIAGNOSED TO HAVE EXCESS ZINC AND RESULTING COPPER DEPLETION. TREATMENT: IN NEED OF CONSTANT UNSPECIFIED CARE, HAS INCURRED UNSPECIFIED MEDICAL COSTS. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33 %, CELL NONE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability