BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 1710468 · Received June 3, 2010

    Report

    Report Number
    1530449-2010-00086
    Event Type
    Death
    Date Received
    June 3, 2010
    Report Date
    May 20, 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
    UNKNOWN

    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

    PARALYSIS [PARALYSIS], COPPER MYELOPATHY, COPPER MYELONEUROPATHY [MYELOPATHY], SENSORIMOTOR POLYNEUROPATHY [PERIPHERAL SENSORIMOTOR NEUROPATHY], MYOPATHY [MYOPATHY], VARIOUS OTHER NEUROLOGICAL DISORDERS, PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER], NEUROPATHY PERIPHERAL], EXCESS ZINC [BLOOD ZINC INCREASED], COPPER DEPLETION [BLOOD COPPER DECREASED], PROFOUND AND PERMANENT INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HER CLIENT, AN (B) (6) FEMALE, USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM, UNSPECIFIED TOTAL DAILY USE AS HER PRODUCT OF CHOICE AS A DENTURE WEARER, AND REPORTED THE FOLLOWING: PARALYSIS, COPPER MYELOPATHY, COPPER MYELONEUROPATHY, SENSORIMOTOR POLYNEUROPATHY, MYOPATHY, VARIOUS OTHER NEUROLOGICAL DISORDERS, PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, NEUROPATHY, EXCESS ZINC AND RESULTING COPPER DEPLETION, AND PROFOUND AND PERMANENT INJURIES WHICH LEFT HER UNABLE TO PERFORM HER NORMAL CUSTOMARY AND DAILY ACTIVITIES. SHE HAD RECEIVED UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CLIENT WAS ADMITTED TO VARIOUS HOSPITALS IN SEARCH OF DETERMINING THE CAUSE OF HER SEVERE STATE OF PARALYSIS WHICH EVENTUALLY LEAD TO HER DEATH AT THE AGE OF (B) (6). THE CASE OUTCOME WAS FATAL. 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 Death| S