BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2223824 · Received August 18, 2011

    Report

    Report Number
    1530449-2011-00131
    Event Type
    Other
    Date Received
    August 18, 2011
    Report Date
    July 28, 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]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. NEUROPATHY [NEUROPATHY PERIPHERAL]. EXCESS ZINC [BLOOD ZINC INCREASED]. COPPER DEPLETION [BLOOD COPPER DECREASED]. HYPOCUPREMIA [COPPER DEFICIENCY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ADULT FEMALE CLIENT, NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM, UNSPECIFIED TOTAL DAILY USE ON FULL UPPER AND LOWER DENTURES SHE RECEIVED IN 1996, LAST KNOWN USE IN (B)(6) 2010, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES, WAS DIAGNOSED WITH NEUROPATHY IN (B)(6) 2010 ATTRIBUTED TO EXCESS ZINC AND RESULTING COPPER DEPLETION, AND HYPOCUPREMIA. TREATMENT: HAS RECEIVED WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - UPPER AND LOWER DENTURE WEARER SINCE 1996. 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 55 YR Disability