BEUDAMED
    FDA Adverse Event Summary report: N

    NEURO PACK

    MDR report key: 7295987 · Received February 23, 2018

    Report

    Report Number
    MW5075521
    Date Received
    February 23, 2018
    Date of Event
    February 8, 2018
    Report Date
    February 22, 2018
    Manufacturer
    UNK
    Product Code
    OIP
    UDI-DI
    10889942564521
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS IN INTERVENTIONAL RADIOLOGY (IR) FOR A STROKE THROMBECTOMY. DURING THE FINAL PASS OF THE DEVICE, WHEN THE MD PULLED THE STENT RETRIEVER OUT, THE TEAM NOTICED A "BLUE" ITEM WITHIN THE BASKET OF THE DEVICE. THIS "BLUE" ITEM WAS NOT NOTICED ON ANY PRIOR USES OF THE DEVICE. THE DEVICE AND OTHER CATHETERS ON THE TABLE WERE COLLECTED AND PLACED INTO A BIOHAZARD BAG. THE ITEM APPEARS TO BE BLUE LINT FROM THE TOWELS IN THE KIT. MEDLINE, US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137372 NEURO PACK RADIOLOGY DIAGNOSTIC KIT OIP UNK 17TB9215 10889942564521

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR