BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2470695 · Received February 24, 2012

    Report

    Report Number
    1530449-2012-00007
    Event Type
    Other
    Date Received
    February 24, 2012
    Report Date
    February 13, 2012
    Manufacturer
    PROCTER & GAMBLE MFG 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 INJURY [INJURY]. ZINC TOXICITY [METAL POISONING]. HEMATOLOGICAL PROBLEMS [BLOOD DISORDER]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR MALE CLIENT, (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM, UNSPECIFIED TOTAL DAILY USE AS DENTURE ADHESIVE BEGINNING 1989 THROUGH 2010, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, ZINC TOXICITY, HEMATOLOGICAL PROBLEMS, AND SEVERE AND PERMANENT PHYSICAL INJURY, INJURIES THAT HAVE LEFT HIM UNABLE TO PERFORM HIS NORMAL CUSTOMARY, AND DAILY ACTIVITIES. THE CONSUMER HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE OUTCOME OF THE CASE WAS: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES AND SEVERE AND PERMANENT PHYSICAL INJURY ¿ NOT RECOVERED/NOT RESOLVED; ALL OTHER SYMPTOMS ¿ UNK. 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 Disability