BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERDENT PLUS

    MDR report key: 337917 · Received March 30, 2001

    Report

    Report Number
    2623619-1999-00001
    Event Type
    Injury
    Date Received
    March 30, 2001
    Date of Event
    October 24, 1999
    Report Date
    January 1, 2001
    Manufacturer
    WARNER LAMBERT CO.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT: PT WHO IS A REGULAR USER OF EFFERDENT PLUS FOR THE PAST COUPLE OF YEARS SOAKED THE PT'S BOTTOM DENTURES IN 1999 AND THEN RINSED THEM UNDER COLD WATER AND PLACED IN MOUTH. WITHIN A MINUTE THE PT FELT A FUNNY TASTE IN THE PT'S MOUTH AND THE PT'S NOSTRILS STARTED TO BURN. THE PT THEN EXPERIENCED DIFFICULTY IN BREATHING AND A BURNING SENSATION IN THE PT'S CHEST AND THROAT AREA. THE PT WALKED OUTSIDE TO GET HELP AND WAS FOUND ON THE GROUND BY THE PT'S FAMILY MEMBER AND TRANSPORTED TO A HEALTH CENTER. THE PT WAS ADMITTED TO A HOSPITAL TRAUMA CENTER AND TREATED WITH OXYGEN, INTRAVENOUS FLUIDS AND UNDERWENT UNSPECIFIED TESTS. THE PT WAS DISCHARGED FROM THE HOSPITAL ON THE NEXT DAY, PHYSICIAN INDICATED THAT THE PT WAS DIAGNOSED WITH PNEUMONITIS DUE TO ASPIRATION OF EFFERDENT SOLUTION. THE PT WAS PRESCRIBED ZANTAC, PREDNISONE AND AN ALBUTEROL INHALER. NO CONCOMITANT MEDICATIONS WERE TAKEN.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT CONSUMER WAS HOSPITALIZED FOR 3 DAYS IN 1999 AND THAT DURING HOSPITALIZATION, FLUID WAS DRAINED FROM THE CONSUMER'S LUNGS. CONSUMER ALSO REPORTED THAT SINCE THIS INCIDENT, CONSUMER CONTINUES TO DEVELOP FLUID IN THE CONSUMER LUNGS THAT CONSTANTLY REQUIRES DRAINAGE, HAS RECURRENT EPISODES OF PNEUMONIA AND HAS DEVELOPED COUGHING, INSOMNIA, ANXIETY ATTACKS AND NOCTURNAL COLD SWEATS. CONSUMER HAS NO KNOWN ALLERGIES. CONSUMER IS CURRENTLY USING ALBUTEROL VIA NEBULIZER 4 TO 5 TIMES DAILY AND UNSPECIFICIED INHALERS TO TREAT THE BREATHING CONDITION, ORAL PREDNISONE FOR FLUID IN THE LUNGS, KLONOPIN (CLONAZEPAM) FOR SLEEP DISORDER AND PAXIL (PAROXETINE) FOR ANXIETY. THE EVENTS HAVE NOT YET RESOLVED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT CONSUMER WAS HOSPITALIZED FOR 2 DAYS IN 1999. X-RAYS, BLOOD WORK, CAT SCAN, MAGNETIC RESONANCE IMAGING AND UNSPECIFIED BREATHING TESTS WERE PERFORMED DURING CONSUMER'S HOSPITALIZION (RESULTS UNSPECIFIED). CONSUMER ALSO PROVIDED CONSUMER'S DATE OF BIRTH (10/1940) AND THE LOT NUMBER (D02159V) FOR EFFERDENT PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14343 EFFERDENT PLUS DENTURE PRODUCT EFT WARNER LAMBERT CO. UNK D02159V

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization