BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1622140 · Received March 2, 2010

    Report

    Report Number
    1530449-2010-00001
    Event Type
    Other
    Date Received
    March 2, 2010
    Date of Event
    March 1, 2009
    Report Date
    February 11, 2010
    Manufacturer
    PROCTER & GAMBLE MFG CO
    Product Code
    KOO
    PMA / PMN Number
    945200
    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. (US) OTC DEVICE.

    Description of Event or Problem · 1

    NEUROPATHY (PROVISIONAL) [NEUROPATHY PERIPHERAL]. PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NEUROLOGICAL COMPLICATION FROM DEVICE]. OTHER PROFOUND AND PERMANENT INJURIES, PHYSICAL INJURIES [INJURY]. DIAGNOSED WITH EXCESS ZINC [HYPERZINCAEMIA]. COPPER DEPLETION [COPPER DEFICIENCY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, AN ADULT FEMALE AGE (B)(6), USED (AND INGESTED) FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM TO IMPROVE DENTURE RETENTION AND COMFORT AND SUFFERED PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES AND OTHER PROFOUND AND PERMANENT INJURIES, WAS DIAGNOSED WITH NEUROPATHY (PROVISIONAL) IN (B)(6) 2009 AND IN THE PAST YR WAS DIAGNOSED WITH EXCESS ZINC AND RESULTING COPPER DEPLETION. SHE HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. BECAUSE OF THE EVENTS, THE CLIENT HAD DISABILITIES AND WAS UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. 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 53 YR Disability