BEUDAMED
    FDA Adverse Event Injury Summary report: N

    83 PLUS

    MDR report key: 778837 · Received October 4, 2006

    Report

    Report Number
    778837
    Event Type
    Injury
    Date Received
    October 4, 2006
    Date of Event
    September 21, 2006
    Report Date
    October 4, 2006
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED ABDOMINAL PAIN AND RECTAL BLEEDING WITHIN HOURS OF SCREENING COLONOSCOPY AND WAS ADMITTED TO HOSPITAL. PAIN AND BLEEDING PROBABLE RESULT OF GLUTARALDEHYDE EXPOSURE CAUSING GLUTARALDEHYDE COLITIS. DISINFECTANT HOSING TO ENDOSCOPE WAS FOUND TO BE CRACKED AND SPLIT. APPEARS HOSING WAS RUBBING AGAINST THE METAL FITTING. NEW ADDITIONAL TUBING INSPECTION WAS ADDED TO THE DISINFECTION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 83 PLUS WASHER, DISINFECTOR FEB CUSTOM ULTRASONICS INC. 83 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R