BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33 % CELLU

    MDR report key: 2223826 · Received August 18, 2011

    Report

    Report Number
    1530449-2011-00133
    Event Type
    Other
    Date Received
    August 18, 2011
    Report Date
    August 10, 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, OTHER NEUROLOGICAL DISORDERS [NERVOUS SYSTEM DISORDER]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. NEUROPATHY [NEUROPATHY PERIPHERAL]. MYELOPATHY [ MYELOPATHY]. HYPERZINCURIA [URINE ABNORMALITY]. ZINC TOXICITY [METAL POISONING]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. HYPOCUPREMIA [COPPER DEFICIENCY]. NUMBNESS [HYPOAESTHESIA]. SEVERE PAIN [PAIN]. TINGLING [PARAESTHESIA]. TREMORS [TREMOR]. CRAMPS [MUSCLE SPASMS]. MUSCLE TWITCHING [MUSCLE TWITCHING]. PARALYSIS [PARALYSIS]. INABILITY TO WALK [ABASIA]. LOSS OF BALANCE [BALANCE DISORDER]. LOSS OF USE OF UPPER AND/OR LOWER EXTREMITIES [MOTOR DYSFUNCTION]. DIFFICULTY BREATHING [DYSPNOEA]. KIDNEY FAILURE [RENAL FAILURE]. LIVER FAILURE [HEPATIC FAILURE]. BONE MARROW DEPLETION [BONE MARROW FAILURE]. ABDOMINAL PAIN [ABDOMINAL PAIN]. NAUSEA [NAUSEA]. VOMITING [VOMITING]. ANEMIA [ANAEMIA]. LETHARGY [LETHARGY]. DEPRESSION [DEPRESSION]. ANXIETY [ANXIETY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT A (B)(6) FEMALE CLIENT USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND SUPER POLIGRIP ORIGINAL, BOTH BEGINNING IN 1994 THROUGH 2011, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, OTHER NEUROLOGICAL DISORDERS, SEVERE AND PERMANENT PHYSICAL INJURIES, NEUROPATHY, MYELOPATHY, HYPERZINCURA, ZINC TOXICITY, EXTENSIVE NERVE DAMAGE, HYPOCUPREMIA, NUMBNESS, SEVERE PAIN, TINGLING, TREMORS, CRAMPS, MUSCLE TWITCHING, PARALYSIS, INABILITY TO WALK, LOSS OF BALANCE, LOSS USE OF UPPER AND/OR LOWER EXTREMITIES, DIFFICULTY BREATHING, KIDNEY FAILURE, LIVER FAILURE, BONE MARROW DEPLETION, ABDOMINAL PAIN, NAUSEA, VOMITING, ANEMIA, LETHARGY, DEPRESSION, AND ANXIETY. THE ATTORNEY STATED HIS CLIENT HAD SEVERE EMOTIONAL AND MENTAL INJURIES, EMOTIONAL DISTRESS, WORRY, AND ANGUISH. HEALTH CARE PROFESSIONAL WAS VISITED. 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 UNKNOWN (CALCIUM ZINC GANTREZ SALT 33 % CELLU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability