BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD

    MDR report key: 12487875 · Received September 17, 2021

    Report

    Report Number
    3003768277-2021-10118
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    June 8, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054202
    PMA / PMN Number
    K161563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT THE PATIENT EXPERIENCED HAIR LOSS AFTER UNDERGOING A BRAIN ARTERIOVENOUS MALFORMATION PROCEDURE ON THE PHILIPS ALLURA X-RAY SYSTEM. THE PATIENT RECEIVED A TOTAL DOSE OF 7.4 GY DURING A TOTAL IRRADIATION TIME OF 4 HOURS AND 35 MINUTES. PHILIPS INSPECTED THE SYSTEM ONSITE AND ANALYZED THE LOG FILE AND NO MALFUNCTION WAS FOUND. DETERMINISTIC EFFECTS OR TISSUE REACTIONS MAY OCCUR WHEN THE RADIATION DOSE HAS EXCEEDED A CERTAIN THRESHOLD LEVEL, WHICH MAY DEPEND ON THE IRRADIATED TISSUE OR ORGAN AND ON THE PATIENT'S SENSITIVITY TO RADIATION. THE THRESHOLD IS TYPICALLY 3 GY FOR TEMPORARY HAIR LOSS. DETERMINISTIC EFFECTS ARE DESCRIBED IN THE INSTRUCTIONS FOR USE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385112 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838054202

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other