BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1914431 · Received November 22, 2010

    Report

    Report Number
    1530449-2010-00130
    Event Type
    Other
    Date Received
    November 22, 2010
    Report Date
    November 10, 2010
    Manufacturer
    PROCTOR & 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 RPTR 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], OTHER PROFOUND PERSONAL INJURIES [INJURY], EXCESS ZINC [BLOOD ZINC INCREASED], COPPER DEPLETION [BLOOD COPPER DECREASED]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, A (B)(6) FEMALE, USED FIXODENT DENTURE ADHESIVE, VERSION UNK 1 APPLIC, UNSPECIFIED FREQUENCY COMMENCING APPROX 1995 THROUGH (B)(6) 2010 AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, OTHER PROFOUND PERSONAL INJURIES, EXCESS ZINC, COPPER DEPLETION. TREATMENT: UNSPECIFIED MEDICAL TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE DEPENDENT. 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 PROCTOR & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability