BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 8000

    MDR report key: 3192577 · Received June 19, 2013

    Report

    Report Number
    3007420694-2013-00030
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z.O.O.
    Product Code
    FNL
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4). ON BEHALF OF THE IMPORTER (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278487 ENTERPRISE 8000 FNL ARJOHUNTLEIGH POLSKA SP. Z.O.O.

    Patients

    Seq Age Sex Outcome Treatment
    1