BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERDENT UNSPECIFIED

    MDR report key: 624918 · Received August 5, 2005

    Report

    Report Number
    2246407-2005-00009
    Event Type
    Other
    Date Received
    August 5, 2005
    Date of Event
    July 24, 2005
    Report Date
    July 29, 2005
    Manufacturer
    PFIZER INC.
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSUMER ACCIDENTALLY INGESTED ONE EFFERDENT TABLET - FORMULATION USPECIFIED (POTASSIUM MONOPERSULFATE, SODIUM PERBORATE MONOHYDRATE) ONCE IN 2005. AFTER INGESTING THE PRODUCT, THEY REPORTED FEELING ILL AND THEIR TONGUE WAS BLUE,. THE CONSUMER WAS HOSPITALIZED (TREATMENT UNSPECIFIED. THE OUTCOME OF THE EVENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERDENT UNSPECIFIED DENTURE PRODUCT KOO PFIZER INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O