BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURION

    MDR report key: 19702816 · Received July 9, 2024

    Report

    Report Number
    3003768277-2024-03732
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 4, 2024
    Report Date
    December 10, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099272
    PMA / PMN Number
    K200917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PATIENT WAS UNDERGOING A NEUROVASCULAR PROCEDURE AND RECEIVED A TOTAL DOSE OF 5.7 GY. PHILIPS INSPECTED THE SYSTEM ONSITE AND ANALYZED THE SYSTEM¿S LOG FILES, CONFIRMING THAT THERE WAS NO SYSTEM MALFUNCTION. PHILIPS HAD PROVIDED THE CUSTOMER WITH TRAININGS ON RADIATION SAFETY, IMAGE QUALITY AND REDUCING DOSE VIA PATIENT AND SYSTEM POSITIONING. AS DESCRIBED IN THE SYSTEM¿S INSTRUCTIONS FOR USE (IFU), THE THRESHOLD DOSE FOR TEMPORARY HAIR LOSS IS TYPICALLY 3GY.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT A PATIENT SUFFERED HAIR LOSS A FEW DAYS AFTER A DIAGNOSIS AND FLOW DIVERTER PROCEDURE USING AN AZURION IMAGING SYSTEM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210699 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B20 00884838099272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other