BEUDAMED
    FDA Adverse Event Death Summary report: N

    CULTURETTE TOXIN CD

    MDR report key: 220327 · Received April 23, 1999

    Report

    Report Number
    1119779-1999-00002
    Event Type
    Death
    Date Received
    April 23, 1999
    Date of Event
    March 24, 1999
    Report Date
    March 24, 1999
    Manufacturer
    BECTON DICKINSON
    Product Code
    LLH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 79 YEAR OLD FEMALE WAS ADMITTED TO THE HOSPITAL FOR UNKNOWN REASONS. DURING THE COURSE OF HOSPITALIZATION SHE WAS PLACED ON MULTIPLE, BROAD-SPECTRUM ANTIBIOTICS FOR SUSPECTED SEPSIS. AT SOME POINT SHE DEVELOPED DIARRHEA, THAT WAS VISUALLY BLOODY AT TIMES. THE SOURCE OF THE BLOOD IN HER STOOLS WAS NEVER DETERMINED AND THE PT SUBSEQUENTLY HAD A NEAR-TOTAL COLECTOMY AND EXPIRED THEREAFTER. SHE HAD FIVE STOOL SPECIMENS TAKEN OVER A PERIOD OF FOUR DAYS WHICH WERE TESTED WITH THE DEVICE. ALL RESULTS WERE REPORTED AS NEGATIVE. THE PATHOLOGY OF THE EXCISED COLON SHOWED "MASSIVE PSEUDOMEMBRANOUS COLITIS," WITHOUT COLONIC PERFORATIONS OR EVIDENCE OF TOXIC MEGACOLON. THERE WAS NEVER ANY CONFIRMATION BY ANY OTHER METHOD THAT CLOSTRIDIUM DIFFICILE WAS THE ETIOLOGIC AGENT FOR THE PSEUDOMEMBRANOUS COLITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CULTURETTE TOXIN CD RAPID IMMUNOASSAY TEST LLH BECTON DICKINSON NA 1000C9FGIF

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death