BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXISKY 600

    MDR report key: 3162283 · Received May 10, 2013

    Report

    Report Number
    9681684-2013-00044
    Event Type
    Injury
    Date Received
    May 10, 2013
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR (B)(4) ON BEHALF OF THE IMPORTER (B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SVC UNIT SUBSIDIARY DIV, NOT A DIRECT EMPLOYEE OF THE MFR. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IMP REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209455 MAXISKY 600 MANUFACTURED CEILING FIXED CASSETTES FSA ARJOHUNTLEIGH MAGOG INC

    Patients

    Seq Age Sex Outcome Treatment
    1