BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2222543 · Received August 11, 2011

    Report

    Report Number
    1530449-2011-00128
    Event Type
    Other
    Date Received
    August 11, 2011
    Report Date
    June 30, 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]. HYPOCUPREMIA [COPPER DEFICIENCY]. NEUROPATHY [NEUROPATHY PERIPHERAL]. EXCESS ZINC [BLOOD ZINC INCREASED]. COPPER DEPLETION [BLOOD COPPER DECREASED]. 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 DENTURES SHE RECEIVED 10 YEARS AGO, 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 ATTRIBUTED TO EXCESS ZINC AND RESULTING COPPER DEPLETION, AND HYPOCUPREMIA. 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 FOR APPROX 10 YEARS. 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 %, CELL DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability