BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSPHERE

    MDR report key: 24845489 · Received April 10, 2026

    Report

    Report Number
    9615728-2026-00065
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    September 9, 2025
    Report Date
    April 10, 2026
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    KRD
    UDI-DI
    00884450403174
    PMA / PMN Number
    K181300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS IDENTIFIED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. UPON REVIEW, THE MANUFACTURER DETERMINED THE EVENT MEETS FDA CRITERIA FOR REPORTING. THE REPORT IS BEING SUBMITTED TO ENSURE ACCURACY AND COMPLETENESS OF MDR FILES. THIS SUBMISSION DOES NOT REFLECT A CHANGE IN DEVICE PERFORMANCE OR PATIENT RISK. THE AWARENESS DATE CORRESPONDS TO WHEN THE MANUFACTURER BECAME AWARE OF THE EVENT DETAILS. ALL INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THIS TIME HAS BEEN INCLUDED. THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THE PATIENT EXPERIENCED HIVES AT THE SITE OF TREATMENT AFTER A GENICULAR ARTERY EMBOLIZATION (GAE) PROCEDURE. THE HIVES SUBSIDED WITH ADMINISTRATION OF BENADRYL. THE DEVICE HAS BEEN DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904343 EMBOSPHERE DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BIOSPHERE MEDICAL, S.A. X3197026-5 00884450403174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention