BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1914433 · Received November 22, 2010

    Report

    Report Number
    1530449-2010-00128
    Event Type
    Other
    Date Received
    November 22, 2010
    Report Date
    November 1, 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 RPTR; 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]; ZINC TOXICITY [METAL POISONING]; NUMBNESS IN LEGS [HYPOAESTHESIA]; LOSS OF COORDINATION [COORDINATION ABNORMAL]; DIFFICULTY MAINTAINING BALANCE [BALANCE DISORDER]; MUSCLE WEAKNESS [MUSCULAR WEAKNESS];PAIN-LEGS [PAIN IN EXTREMITY]; SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, AN ADULT MALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM BEGINNING (B)(6) 2006 TO PRESENT, AFTER USING SUPER POLIGRIP DENTURE ADHESIVE CREAM (B)(6) 2006, UNSPECIFIED TOTAL DAILY APPLICATIONS FOR HIS PERSONAL USE, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, ZINC TOXICITY AND EXTENSIVE NERVE DAMAGE RESULTING IN SYMPTOMS THAT INCLUDE NUMBNESS IN LEGS, PAIN IN LEGS, MUSCLE WEAKNESS, LOSS OF COORDINATION, AND DIFFICULTY MAINTAINING BALANCE. TREATMENT: HAS REC'D 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, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability