BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSPHERE MICROSPHERES

    MDR report key: 3855793 · Received April 16, 2014

    Report

    Report Number
    9615728-2014-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    NAJ
    PMA / PMN Number
    K021397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED DEVICE RETURNED FOR EVALUATION. THE EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT A FIBER/HAIR WAS IDENTIFIED IN THE BARREL OF THE SYRINGE DURING THEIR 100% INSPECTION OF RECEIVED PRODUCT. THE DEVICE WAS NOT SENT TO A USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233723 EMBOSPHERE MICROSPHERES AGENTS, EMBOLIC, FOR TREATMENT OF UF NAJ BIOSPHERE MEDICAL, S.A. X570815-5

    Patients

    Seq Age Sex Outcome Treatment
    1