BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK INC.

    MDR report key: 139566 · Received December 19, 1997

    Report

    Report Number
    139566
    Event Type
    Injury
    Date Received
    December 19, 1997
    Date of Event
    December 3, 1997
    Report Date
    December 17, 1997
    Manufacturer
    COOK, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING NEPHROSTOMY WIRE PLANT, THE TIPS OF TWO DIFFERENT MANDRIL WIRES BECAME SEPERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK INC. MANDRIL WIRES DQX COOK, INC. SMG-18-60-COPE *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention