BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERDENT ANTI BACTERIAL DENTURE CLEANSE

    MDR report key: 765260 · Received September 25, 2006

    Report

    Report Number
    2246407-2006-00008
    Event Type
    Other
    Date Received
    September 25, 2006
    Date of Event
    August 13, 2006
    Report Date
    September 18, 2006
    Manufacturer
    PFIZER INC
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR FAILURE ANALYSIS/LABORATORY TESTING. USER ERROR MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HIS GRANDFATHER HAS BEEN SOAKING HIS DENTURES WITH EFFERDENT ANTI-BACTERIAL DENTURE CLEANSER TABLET SOLUTION (SODIUM PERBORATE MONOHYDRATE, POTASSIUM MONOPERSULFATE) SINCE AN UNSPECIFIED DATE IN 2004 (ONE AND A HALF YEARS AGO.) HE REPORED THAT HIS GRANDFATHER WOULD START HALLUCINATING AFTER HE SOAKED HIS DENTURES AND PUT THEM ON. IN 2006, HE ACCIDENTALLY INGESTED AN UNK AMOUNT OF EFFERDENT ANTI BACTERIAL DENTURE CLEANSER TABLET SOLUTION. THE CONSUMER REPORTED THAT HE TOOK HIS GRANDFATHER TO THE HOSPITAL PRIOR TO THE EVENT DATE AND HE WAS ADMITTED. THEY CLEANED HIS STOMACH AND SOME UNSPECIFIED BLOOD TESTING WAS PERFORMED (RESULTS UNSPECIFIED) AT THE TIME OF REPORTING ON 18 SEP 2006, THE OUTCOME OF THE EVENTS WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERDENT ANTI BACTERIAL DENTURE CLEANSE DENTURE PRODUCT EFT PFIZER INC * BH1162V

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| O