BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2101185 · Received May 19, 2011

    Report

    Report Number
    1530449-2011-00091
    Event Type
    Other
    Date Received
    May 19, 2011
    Report Date
    May 4, 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

    PERMANENT BODILY INJURY [INJURY]. NEUROLOGICAL DAMAGES [NERVOUS SYSTEM DISORDER]. HEAVY METAL (ZINC) POISONING [METAL POISONING]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, AN ADULT MALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM FOR HIS DENTURES, UNSPECIFIED TOTAL DAILY USE BEGINNING (B)(6) 1998 THROUGH (B)(6) 2009, AND REPORTED THE FOLLOWING: PERMANENT BODILY INJURY, NEUROLOGICAL DAMAGES, AND HEAVY METAL (ZINC) POISONING. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. 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 %, CELL DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability