BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2116786 · Received May 31, 2011

    Report

    Report Number
    1530449-2011-00096
    Event Type
    Other
    Date Received
    May 31, 2011
    Report Date
    May 13, 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

    SUSTAINED PERMANENT INJURY, SUFFERED IRREPARABLE PHYSICAL INJURY [INJURY]. NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. TREMORS IN EXTREMITIES [TREMOR]. BALANCE PROBLEMS [BALANCE DISORDER]. BLURRED VISION [VISION BLURRED]. CASE DESCRIPTION. AN ATTORNEY REPORTED THAT HIS CLIENT, AN ADULT MALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN AND POLIGRIP DENTURE ADHESIVE CREAM AND REPORTED THE FOLLOWING: SUSTAINED PERMANENT INJURY, SUFFERED IRREPARABLE PHYSICAL INJURY, NEUROLOGICAL INJURIES, TREMORS IN EXTREMITIES, BALANCE PROBLEMS, BLURRED VISION. TREATMENT: UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. 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 Disability