BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSPHERE MICROSPHERES

    MDR report key: 2216962 · Received July 26, 2011

    Report

    Report Number
    9615728-2011-00001
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    July 28, 2010
    Report Date
    July 20, 2011
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    NAJ
    PMA / PMN Number
    K021397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF MAUDE DATABASE, EVENT SEEN AND DOCUMENTED AS COMPLAINT AT BIOSPHERE MEDICAL, INC. THE EVENT WAS DETERMINED TO BE REPORTABLE. PT AND PHYSICIAN ARE UNK. FROM INVESTIGATION AND REVIEW OF EVENT REPORTED BY PT, THE DEVICE UTILIZED BY THE PHYSICIAN WAS EXPIRED AND THERE WAS NO EVIDENCE THE DEVICE FAILED OR MALFUNCTIONED. A DETAILED DEVICE HISTORY RECORD WAS PERFORMED. ALL ANALYTICAL, BIOLOGICAL, AND MICROBIOLOGICAL DATA WAS REVIEWED AND FOUND TO CONFORM TO ALL SPECIFICATIONS. THERE HAVE BEEN NO NON-CONFORMANCE OR OTHER COMPLAINTS ON THIS PRODUCT LOT. THE LOT MET ALL REQUIREMENTS OF MANUFACTURING AND CONTROL SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, BIOSPHERE MEDICAL, INC., BECAME AWARE OF AN INCIDENT INVOLVING A PT. ON (B)(6), 2010, PT UNDERWENT PRE-SURGICAL EMBOLIZATION OF HIGHLY VASCULARIZED BRAIN TUMOR PRIOR TO CRANIOTOMY. FOLLOWING THE PROCEDURE, THE PT REPORTED GOING BLIND IN RIGHT EYE. PT VOLUNTARILY SUBMITTED REPORT TO FDA ON (B)(6) 2011. REFERENCE REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSPHERE MICROSPHERES NAJ BIOSPHERE MEDICAL, S.A. 184GB8

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability