BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM ULTRA SONIC INC

    MDR report key: 257657 · Received January 4, 2000

    Report

    Report Number
    257657
    Event Type
    Injury
    Date Received
    January 4, 2000
    Date of Event
    November 15, 1999
    Report Date
    January 3, 2000
    Manufacturer
    *
    Product Code
    FLG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT COLONOSCOPY IN 1999 PRESENTED TO ER WITH COMPLAINT OF NAUSEA, DIARRHEA, ABDOMINAL CRAMPING. FLEXIBLE SIGMOIDOSCOPY PERFORMED REVEALED COLITIS. PT ADMITTED TO HOSP FOR HYDRATION. PAIN CONTROL, AND MONITORING FOR POSSIBLE BOWEL PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRA SONIC INC ENDOSCOPIC WASHER FLG * 83-9 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization