BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU

    MDR report key: 1651936 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00014
    Event Type
    Other
    Date Received
    April 5, 2010
    Report Date
    September 29, 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

    PROFOUND AND PERMANENT NEUROLOGICAL DAMAGE [NERVOUS SYSTEM DISORDER], OTHER INJURIES, PHYSICAL INJURIES [INJURY], ZINC TOXICITY [METAL POISONING], COPPER DEFICIENCY [COPPER DEFICIENCY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, AN ADULT, FEMALE, AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM AND SUPER POLIGRIP ORIGINAL CREAM FOR THEIR INTENDED PURPOSE FOR OVER 30 YEARS, LAST KNOWN USE IN (B)(6) 2009, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL DAMAGE, ZINC TOXICITY, COPPER DEFICIENCY, AND PHYSICAL INJURIES AND OTHER INJURIES LEAVING 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. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU NONE KOO PROCTER & GAMBLE CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability