BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK, INC.

    MDR report key: 123825 · Received October 2, 1997

    Report

    Report Number
    123825
    Event Type
    Injury
    Date Received
    October 2, 1997
    Date of Event
    September 28, 1997
    Report Date
    October 2, 1997
    Manufacturer
    COOK, INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR PERCUTANEOUS NEPHROLITHOTOMY. WHEN IN THE OR MASSIVE AMOUNTS OF BLEEDING OCCURRED. AT THAT TIME THEY ABORTED THE PROCEDURE. ON 9/28/97 AT 11:00 PM AN EMBOLECTOMY NEEDED TO BE PERFORMED. THE COIL USED WAS SUPPOSED TO OCCLUDE THE ARTERY TO STOP BLEEDING. HOWEVER, THE COIL STRAIGHTENED OUT AND PART WENT INTO THE RENAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK, INC. Implant EMBOLISM COIL (5CM, 5MM) KRD COOK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention