BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAILBU/SOVEREIGN (INCL DIGNITY)

    MDR report key: 3221100 · Received July 5, 2013

    Report

    Report Number
    9611530-2013-00080
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MFR, ARJO (B)(4), ON BEHALF OF THE IMPORTER, (B)(4). ADDITIONAL INFORMATION 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
    307577 MAILBU/SOVEREIGN (INCL DIGNITY) ILM ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1