BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSPHERE MICROSPHERES

    MDR report key: 3599037 · Received January 24, 2014

    Report

    Report Number
    9615728-2014-00001
    Event Type
    Injury
    Date Received
    January 24, 2014
    Date of Event
    June 8, 2012
    Report Date
    January 15, 2014
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    NAJ
    PMA / PMN Number
    K021397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND THE COMPLAINT DATABASE COULD NOT BE REVIEWED FOR LOT SPECIFIC INFORMATION AS NO CATALOG OR LOT NUMBER WAS PROVIDED. PMA/510 (K) NUMBER IS AN ESTIMATE. MERIT HAS RECEIVED ONE COMPLAINT WHEREBY THE PT REPORTED 'PARTIAL VISION LOSS' POST UTERINE FIBROID EMBOLIZATION (UFE). REFERENCE MANUFACTURER REPORT # 9615728-2013-00003 FOR SPECIFIC INFORMATION. THIS COMPLAINT WAS PROVIDED TO THE MANUFACTURER THROUGH THE FDA MEDWATCH PROGRAM. PLEASE REFERENCE ATTACHED COPY OF REPORT RECEIVED. MERIT IS UNABLE TO OBTAIN ADDITIONAL INFORMATION OR DETERMINE A ROOT CAUSE WITHOUT ADDITIONAL INFORMATION. THIS COMPLAINT IS UNCONFIRMED. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT INCURRED IMPAIRED VISION POST UTERINE FIBROID EMBOLIZATION (UFE) PROCEDURE. THE MANUFACTURER WAS MADE AWARE OF THIS ADVERSE EVENT THROUGH THE FDA'S MEDWATCH PROGRAM. NO OTHER INFORMATION WAS PROVIDED OR HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57762 EMBOSPHERE MICROSPHERES AGENTS, EMBOLIC, FOR UFE NAJ BIOSPHERE MEDICAL, S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability