BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERDENT ANTIBACTERIAL DENTURE CLEANSER

    MDR report key: 311722 · Received January 10, 2001

    Report

    Report Number
    2623619-2001-00001
    Event Type
    Injury
    Date Received
    January 10, 2001
    Date of Event
    December 19, 2000
    Report Date
    January 8, 2001
    Manufacturer
    WARNER LAMBERT CO.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT CONSUMER'S PARENT, WITH A HISTORY OF ALZHEIMER'S DISEASE, MISTAKENLY INGESTED 1/2 TABLET OF EFFERDENT ANTI-BACTERIAL DENTURE CLEANSER (POTASSIUM MONOPERSULFATE, NA PERBORATE MONOHYDRATE) DISSOLVED IN WATER ONCE IN DEC 2000. AFTER THE INGESTION, THE PT FELT SICK IN THE STOMACH AND BECAME SLEEPY. PT WAS TAKEN TO THE ER AND WAS SUBSEQUENTLY ADMITTED TO THE HOSP FOR OBSERVATION AND TESTING. BOTH ADVERSE EVENTS RESOLVED THAT SAME DAY WITHOUT TREATMENT. UPON ADMISSION, AN X-RAY WAS PERFORMED WHICH REVEALED A PELVIC FRACTURE. UPTO 3 DAYS LATER THE CONSUMER WAS STILL HOSPITALIZED FOR THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998 EFFERDENT ANTIBACTERIAL DENTURE CLEANSER DENTURE PRODUCT EFT WARNER LAMBERT CO. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization