BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33 PERCENT CEL

    MDR report key: 2170229 · Received July 5, 2011

    Report

    Report Number
    1530449-2011-00115
    Event Type
    Other
    Date Received
    July 5, 2011
    Report Date
    June 14, 2011
    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], SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY], HYPOCUPREMIA [COPPER DEFICIENCY], EXTENSIVE NERVE DAMAGE [NERVE INJURY], TINGLING IN LEGS AND HANDS [PARAESTHESIA], NUMBNESS IN LEGS AND HAND [HYPOAESTHESIA], BURNING IN LEGS AND HANDS [BURNING SENSATION], PAIN IN LEGS AND HANDS [PAIN IN EXTREMITY], WEAKNESS IN LEGS AND HANDS [MUSCULAR WEAKNESS], LOSS OF CONTROL IN LEGS AND HANDS [MOTOR DYSFUNCTION], DIFFICULTY WALKING [GAIT DISTURBANCE]. AN ATTORNEY REPORTED THAT A (B)(6) MALE CLIENT USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM 1 APPLIC, UNSPECIFIED FREQUENCY BEGINNING IN 1986 TO 2010 AND SUPERPOLIGRIP BEGINNING IN 1986, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, HYPOCUPREMIA, EXTENSIVE NERVE DAMAGE, TINGLING IN LEGS AND HANDS, NUMBNESS IN LEGS AND HANDS, BURNING IN LEGS AND HANDS, PAIN IN LEGS AND HANDS, WEAKNESS IN LEGS AND HANDS, LOSS OF CONTROL IN LEGS AND HANDS, AND DIFFICULTY WALKING. TREATMENT: UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. DOSE, FREQUENCY AND ROUTE USED: UNK, INTRAORAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33 PERCENT CEL DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability