BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXISKY 440

    MDR report key: 3140158 · Received May 24, 2013

    Report

    Report Number
    9681684-2013-00050
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FNG
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJOHUNTLEIGH (B)(4). ON BEHALF OF THE IMPORTER (B)(4). THE DEVICE WILL BE 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
    232752 MAXISKY 440 MANUFACTURED PORTABLE CASSETTES FNG ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1