BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2163589 · Received June 2, 2011

    Report

    Report Number
    1530449-2011-00098
    Event Type
    Other
    Date Received
    June 2, 2011
    Report Date
    May 9, 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]. ZINC TOXICITY [METAL POISONING]. COPPER DEFICIENCY [COPPER DEFICIENCY]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. MUSCLE WEAKNESS [MUSCULAR WEAKNESS]. LOSS OF COORDINATION [COORDINATION ABNORMAL]. DIFFICULTY MAINTAINING BALANCE [BALANCE DISORDER]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HIS CLIENT A (B)(6) FEMALE, USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, ZINC TOXICITY, COPPER DEFICIENCY, EXTENSIVE NERVE DAMAGE, MUSCLE WEAKNESS, LOSS OF COORDINATION, DIFFICULTY MAINTAINING BALANCE, SEVERE AND PERMANENT PHYSICAL INJURIES. HEALTH CARE PROFESSIONAL WAS VISITED. TREATMENT: UNSPECIFIED MEDICAL CARE, UNSPECIFIED MEDICATIONS. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER. NO FURTHER INFORMATION 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 73 YR Disability