BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSPHERE®

    MDR report key: 23851773 · Received December 19, 2025

    Report

    Report Number
    1721504-2025-00764
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    December 2, 2019
    Report Date
    December 19, 2025
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    HCG
    UDI-DI
    00884450402948
    PMA / PMN Number
    K181300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE REPORTED A DELAYED PYOMYOMA 42 DAYS AFTER UTERINE FIBROID EMBOLIZATION USING EMBOSPHERE MICROSPHERES. THE PATIENT PRESENTED WITH FEVER, ABDOMINAL PAIN, LEUKOCYTOSIS, AND REQUIRED TRANSCERVICAL DRAINAGE. HISTOLOGY CONFIRMED NECROTIC TISSUE AND MICRO-ABSCESS FORMATION. NO DEVICE MALFUNCTION IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259089 EMBOSPHERE® EMBOLIZATION PARTICLE, NON-BIOABSORBABLE HCG BIOSPHERE MEDICAL, S.A. 00884450402948

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention