BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK

    MDR report key: 3893772 · Received June 19, 2014

    Report

    Report Number
    MW5036779
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 18, 2014
    Manufacturer
    COOK
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD UPPER ENDOSCOPY ON (B)(6) 2014 THAT WENT SMOOTHLY. HE PRESENTED 2 DAYS LATER WITH AN INTESTINAL OBSTRUCTION DUE TO A DUODENAL HEMATOMA AND WAS ADMITTED ON (B)(6) 2014 AND IS BEING KEPT NPO ON IVF & NG DECOMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361792 COOK CAPTURA BIOPSY FORCEPS FCL COOK W 3415225

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention