BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXISKY 600

    MDR report key: 3771224 · Received January 14, 2014

    Report

    Report Number
    9681684-2014-00005
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS INSPECTED ON SITE BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE 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
    37845 MAXISKY 600 FSA ARJOHUNTLEIGH MAGOG INC

    Patients

    Seq Age Sex Outcome Treatment
    1