BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1971926 · Received January 24, 2011

    Report

    Report Number
    1530449-2011-00006
    Event Type
    Other
    Date Received
    January 24, 2011
    Report Date
    January 5, 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

    SEVERE AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. BACK PAIN [BACK PAIN]. NUMBNESS IN UPPER AND LOWER EXTREMITIES AND BACK [HYPOAESTHESIA]. ZINC TOXICITY [METAL POISONING]. NERVE DAMAGE [NERVE INJURY]. PAIN IN THE UPPER AND LOWER EXTREMITIES [PAIN IN EXTREMITY]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT A (B)(6) MALE, USED FIXODENT DENTURE ADHESIVE, VERSION UNK 1 APPLIC, UNSPECIFIED FREQUENCY AND SUPERPOLIGRIP DENTURE ADHESIVE BEGINNING IN 1988 THROUGH THE PRESENT AND REPORTED THE FOLLOWING: SUFFERS FROM SEVERE AND PERMANENT NEUROLOGICAL INJURIES, BACK PAIN, NUMBNESS IN UPPER AND LOWER EXTREMITIES AND BACK, ZINC TOXICITY, NERVE DAMAGE, PAIN IN UPPER AND LOWER EXTREMITIES, SEVERE AND PERMANENT PHYSICAL INJURIES. TREATMENT UNSPECIFIED MEDICAL CARE AND TREATMENT. 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 UNKNOWN (CALCIUM ZINC GANTREZ SALT 33% CELLUL DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability