BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTROY

    MDR report key: 3201487 · Received June 27, 2013

    Report

    Report Number
    9611530-2013-00067
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FNG
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BEING SUBMITTED UNDER (B)(4) BY THE MFR ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294231 ENTROY FNG ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1