BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1971941 · Received January 24, 2011

    Report

    Report Number
    1530449-2011-00005
    Event Type
    Other
    Date Received
    January 24, 2011
    Report Date
    January 5, 2011
    Manufacturer
    PROCTER & GAMBLE MFG 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]. SEVERE AND PERMANENT PHYSICAL AND OTHER INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ADULT MALE CLIENT, NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND/OR SUPER POLIGRIP DENTURE ADHESIVE CREAM, UNSPECIFIED TOTAL DAILY USE ON DENTURES HE RECEIVED APPROX 20 YEARS AGO, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL AND OTHER INJURIES THAT HAVE LEFT HIM UNABLE TO PERFORM HIS NORMAL, CUSTOMARY AND DAILY ACTIVITIES. 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 INFO 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 MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability