BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1912908 · Received November 11, 2010

    Report

    Report Number
    1530449-2010-00126
    Event Type
    Other
    Date Received
    November 11, 2010
    Report Date
    October 22, 2010
    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]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. LOSS THE USE OF HIS ARMS INCLUDING THE ABILITY TO LIFT OR FEED HIMSELF [MONOPARESIS]. HYPOCUPREMIA [COPPER DEFICIENCY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THEIR (B)(6) MALE CLIENT USED FIXODENT DENTURE ADHESIVE, VERSION UNK, CREAM BEGINNING IN 2007 THROUGH 2008, AFTER USING SUPER POLIGRIP BEGINNING IN 1974 THROUGH 2007, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, EXTENSIVE NERVE DAMAGE, SEVERE AND PERMANENT PHYSICAL INJURIES, LOSS THE USE OF HIS ARMS INCLUDING THE ABILITY TO LIFT OR FEED HIMSELF, AND HYPOCUPREMIA. TREATMENT: 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, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability