BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1661745 · Received April 15, 2010

    Report

    Report Number
    1530449-2010-00065
    Event Type
    Other
    Date Received
    April 15, 2010
    Report Date
    March 30, 2010
    Manufacturer
    PROCTER & GAMBLE MFG 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 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]. NEUROPATHY [NEUROPATHY PERIPHERAL]. EXCESS ZINC [BLOOD ZINC INCREASED]. COPPER DEPLETION [BLOOD COPPER DECREASED]. PROFOUND AND PERMANENT OTHER AND PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, A FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM, AS HER DENTURE ADHESIVE PRODUCT OF CHOICE, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES; NEUROPATHY DIAGNOSED IN 2006, ON (B)(6) 2009 DIAGNOSED WITH EXCESS ZINC RESULTING IN COPPER DEPLETION; PROFOUND AND PERMANENT NEUROLOGICAL AND OTHER PHYSICAL INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES. SHE HAD 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 UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU NONE KOO PROCTER & GAMBLE MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability