BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUROS

    MDR report key: 4023073 · Received July 15, 2014

    Report

    Report Number
    4023073
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 15, 2014
    Manufacturer
    IVERA MEDICAL
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CUROS CAPS ARE BREAKING WHILE PATIENTS ARE MOVING AROUND IN BED AND ALSO BREAK APART AS THE NURSE REMOVES THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412935 CUROS SET, ADMINISTRATION, INTRAVASCULAR LKB IVERA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR