BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1647349 · Received March 30, 2010

    Report

    Report Number
    1530449-2010-00017
    Event Type
    Other
    Date Received
    March 30, 2010
    Report Date
    March 15, 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 THE REPORTER; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. OTHER SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. ZINC POISONING [METAL POISONING]. COPPER DEFICIENCY. DEVICE INEFFECTIVE (FIXODENT FAILED TO SECURE DENTURES)[DEVICE INEFFECTIVE]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HIS CLIENT, AN ADULT FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM ON HER DENTURES FOR AT LEAST 8 YEARS, BEGINNING 2001 THROUGH 2009, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, OTHER SEVERE AND PERMANENT PHYSICAL INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES, ZINC POISONING, COPPER DEFICIENCY, AND DEVICE INEFFECTIVE (FIXODENT FAILED TO SECURE DENTURES). TREATMENT: RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: DENTURE WEARER FOR OVER 8 YEARS. 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 NONE KOO PROCTER & GAMBLE MFG. CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability