BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD

    MDR report key: 11920551 · Received June 2, 2021

    Report

    Report Number
    3003768277-2021-10024
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    May 24, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054202
    PMA / PMN Number
    K162859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PATIENT WAS UNDERGOING A CEREBRAL EMBOLIZATION PROCEDURE AND RECEIVED A TOTAL DOSE OF 7.7 GY. TOTAL IRRADIATION TIME WAS 1 HOUR AND 36 MINUTES. PHILIPS INSPECTED THE SYSTEM ONSITE AND ANALYZED THE LOG FILE AND NO MALFUNCTION WAS FOUND. AS DESCRIBED IN THE INSTRUCTIONS FOR USE (4522 203 28862 CHAPTER 2.1), THE THRESHOLD FOR TEMPORARY HAIR LOSS IS TYPICALLY 3 GY.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT THE PATIENT EXPERIENCED HAIR LOSS AFTER UNDERGOING A PROCEDURE ON THE PHILIPS ALLURA X-RAY SYSTEM. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817285 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 48 YR Other