BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO EMBO TRAY

    MDR report key: 12590030 · Received October 6, 2021

    Report

    Report Number
    MW5104450
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 4, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC. - LAREDO
    Product Code
    OJG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PROVIDER WAS PERFORMING AN INTRACRANIAL EMBOLIZATION ON A PATIENT. DURING THE PROCEDURE, THE PROVIDER NOTICED THAT THERE WERE FINE FIBERS ON THE MICROWIRE USED FOR THE EMBOLIZATION. IT WAS FELT THAT THE FIBERS WERE LIKELY FROM THE DRAPES (WHICH HAD RECENTLY BEEN CHANGED BY THE SUPPLIER). THE DRAPES WERE INCLUDED IN A NEURO EMBO TRAY KIT AND ALL THE STOCKED KITS WERE CHECKED AND THOSE WITH THE SAME LOT NUMBER WERE REMOVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485125 NEURO EMBO TRAY NEUROLOGICAL TRAY OJG MEDLINE INDUSTRIES, INC. - LAREDO 21HBO722

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR