BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, CONTROL, FLAVOR UNK (CALCIUM ZINC GANTREZ SALT 33%, C

    MDR report key: 1651935 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00015
    Event Type
    Other
    Date Received
    April 5, 2010
    Report Date
    September 15, 2009
    Manufacturer
    PROCTER & GAMBLE 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 THE REPORTER; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    DIAGNOSED WITH NEUROPATHY [NEUROPATHY PERIPHERAL], EXCESS ZINC [BLOOD ZINC INCREASED], RESULTING COPPER DEPLETION [BLOOD COPPER DECREASED], PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER], SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HIS CLIENT, AN ADULT, FEMALE, AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, CONTROL, FLAVOR UNK CREAM AND SUPER POLIGRIP ORIGINAL CREAM AS DENTURE ADHESIVES OF CHOICE TO HOLD DENTURES SHE RECEIVED APPROX FOUR YEARS AGO AND REPORTED THE FOLLOWING: DIAGNOSED WITH NEUROPATHY, EXCESS ZINC, RESULTING COPPER DEPLETION, PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, AND SEVERE AND PERMANENT PHYSICAL INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES. TREATMENT: HAS 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, CONTROL, FLAVOR UNK (CALCIUM ZINC GANTREZ SALT 33%, C DENTURE ADHESIVE KOO PROCTER & GAMBLE CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability