BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERDENT ANTIBACTERIAL DENTURE CLEANSER

    MDR report key: 279528 · Received May 17, 2000

    Report

    Report Number
    2623619-2000-00001
    Event Type
    Injury
    Date Received
    May 17, 2000
    Date of Event
    April 4, 2000
    Report Date
    May 15, 2000
    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 A FAMILY MEMBER, WHO LIVES IN A NURSING HOME AND HAD A PRE-EXISTING CONDITION OF BRONCHITIS, INGESTED APPROXIMATELY 6 EFFERDENT TABLETS. ON 4/4/00 PT WAS FOUND FOAMING AT THE MOUTH WITH A DISTENDED CHEST. PT HAD DIFFICULTY BREATHING AND AN IRRITATED ESOPHAGUS. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND THE CONSUMER WAS TAKEN TO THE HOSP. PT WAS ADMITTED WITH PNEUMONIA AND TREATED WITH INTRAVENOUS ANTIBIOTICS. AS OF 4/6/00, THE CONSUMER IS STILL HOSPITALIZED BUT IMPROVING. FURTHER INFO IS AWAITED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization