BEUDAMED
    FDA Adverse Event Other Summary report: N

    EMBOSPHERE MICROSPHERES

    MDR report key: 472591 · Received May 7, 2003

    Report

    Report Number
    1226551-2003-00007
    Event Type
    Other
    Date Received
    May 7, 2003
    Date of Event
    July 27, 2000
    Manufacturer
    BIOSPHERE MEDICAL, SA BAT A-PARC DES NATIONS
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS EMBOLIZED FOR A SPINAL HEMANGIOMA AT THE T-9 LEVEL. PT DEVELOPED PERIPHERAL PARALYSIS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSPHERE MICROSPHERES ARTIFICIAL EMBOLIC - HCG HCG BIOSPHERE MEDICAL, SA BAT A-PARC DES NATIONS 40-120 MICRONS E160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability