BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 1700940 · Received May 26, 2010

    Report

    Report Number
    1530449-2010-00085
    Event Type
    Death
    Date Received
    May 26, 2010
    Date of Event
    January 1, 2009
    Report Date
    May 18, 2010
    Manufacturer
    PROCTER & GAMBLE MFG CO.
    Product Code
    KOO
    PMA / PMN Number
    (US) OTC DEV
    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. PMA/510(K)#K945200.

    Description of Event or Problem · 1

    PERIPHERAL NEUROPATHY OF HANDS AND FEET [NEUROPATHY PERIPHERAL], WEAKNESS IN LEGS [MUSCULAR WEAKNESS], VOMITING [VOMITING], NAUSEA [NAUSEA], INCONTINENCE [INCONTINENCE], INJURIES [INJURY], HYPOCUPREMIA [COPPER DEFICIENCY], HYPERZINCEMIA [HYPERZINCAEMIA]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HER CLIENT, A FEMALE WITH AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM TO SECURE HER DENTURES, UNSPECIFIED TOTAL DAILY USE BEGINNING 1992 THROUGH 2009, AND REPORTED THE FOLLOWING: PERIPHERAL NEUROPATHY OF HANDS AND FEET AND WEAKNESS IN LEGS BEGINNING (B) (6) 2009, RAPIDLY PROGRESSED TO VOMITING, NAUSEA, AND INCONTINENCE, INJURIES, HYPOCUPREMIA, AND HYPERZINCEMIA. THE CLIENT WAS CONFINED TO A WHEELCHAIR AND RECEIVED SUBSTANTIAL UNSPECIFIED MEDICAL AND HOSPITAL TREATMENT BEFORE PASSING AWAY AS A RESULT OF DEGENERATION, SECONDARY TO HYPOCUPREMIA AND HYPERZINCEMIA, ON (B) (6) 2009. THE CASE OUTCOME WAS FATAL. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER. 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 MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death