BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2143090 · Received June 23, 2011

    Report

    Report Number
    1530449-2011-00104
    Event Type
    Injury
    Date Received
    June 23, 2011
    Report Date
    June 1, 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

    SERIOUS AND PERMANENT PHYSICAL INJURY [INJURY]. PHYSICAL PAIN [PAIN]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT A FEMALE CLIENT, AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM 1 APPLIC, UNSPECIFIED FREQUENCY FOR HER DENTURES BEGINNING IN 2002 AND REPORTED THE FOLLOWING: SERIOUS AND PERMANENT PHYSICAL INJURY AND PHYSICAL PAIN. THE CONSUMER WAS ADMITTED TO THE HOSPITAL. TREATMENT: UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER. 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 Hospitalization| S