BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERDENT ANTIBACTERIAL DENTURE CLEANSER

    MDR report key: 315350 · Received February 8, 2001

    Report

    Report Number
    2623619-2001-00002
    Event Type
    Injury
    Date Received
    February 8, 2001
    Date of Event
    December 29, 2000
    Report Date
    February 7, 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, WITH A 5 YEAR HISTORY OF ESOPHAGEAL ULCER, ACCIDENTALLY INGESTED 1 EFFERDENT ANTIBACTERIAL DENTURE CLEANSER TABLET (POTASSIUM MONOPERSULFATE, NA PERBORATE MONOHYDRATE) IN 12/00. NO ADVERSE EVENT WAS NOTED AFTER THE INGESTION. 10 DAYS LATER, THE CONSUMER BEGAN FEELING WEAK AND CONFUSED. THE CONSUMER WAS TAKEN TO AN EMERGENCY ROOM. A CAT SCAN, ESOPHAGOGASTRODUODENOSCOPY AND COLONOSCOPY WERE PERFORMED WHICH REVEALED A BLEEDING ESOPHAGEAL ULCER. THE CONSUMER WAS SUBSEQUENTLY ADMITTED FOR HOSPITALIZATION AND THE CONSUMER RECEIVED A BLOOD TRANSFUSION. CONSUMER'S AXID (NIZATIDINE) THERAPY WAS CHANGED TO PROPULSID (CISAPRIDE) AND THE CONSUMER WAS GIVEN IRON AND VITAMIN C. THE CONSUMER WAS DISCHARGED FROM THE HOSPITAL IN 1/01 AND TRANSFERRED TO A REHABILITATION CENTER FOR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4716 EFFERDENT ANTIBACTERIAL DENTURE CLEANSER DENTURE PRODUCT EFT WARNER-LAMBERT CO. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization