BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERDENT UNSPECIFIED

    MDR report key: 623415 · Received July 28, 2005

    Report

    Report Number
    2246407-2005-00008
    Event Type
    Other
    Date Received
    July 28, 2005
    Date of Event
    July 19, 2005
    Report Date
    July 26, 2005
    Manufacturer
    PFIZER INC,
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER ACCIDENTALLY INGESTED ONE TABLET OF EFFERDENT-FORMULATION UNSPECIFIED (SODIUM PERBORATE MONOHYDRATE, POTASSIUM MONOPERSULFATE) ONCE IN 2005, IMMEDIATELY AFTER PRODUCT INGESTION, CONSUER VOMITED. APPROXIMATELY 2.5 HOURS LATER, CONSUMER WAS HAVING DIFFICULTY TALKING AND STANDING AND CONSUMER FELT VERY SWEATY. AS OF 2005, THE OUTCOME OF THE EVENT IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other