BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1661741 · Received April 15, 2010

    Report

    Report Number
    1530449-2010-00062
    Event Type
    Other
    Date Received
    April 15, 2010
    Report Date
    March 22, 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 TE 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]. OTHER SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND SUPER POLIGRIP AS HER DENTAL ADHESIVES OF CHOICE, TO IMPROVE DENTURE RETENTION AND COMFORT, AN REPORTED THE FOLLOWING: DIAGNOSED WITH NEUROPATHY IN 2009; DIAGNOSED WITH EXCESS ZINC, RESULTING IN COPPER DEPLETION; SUFFERS FROM PROFOUND AND PERMANENT NEUROLOGICAL INJURIES; OTHER SEVERE AND PERMANENT PHYSICAL INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES. SHE HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. 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 57 YR Disability