BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI 500

    MDR report key: 3841280 · Received May 20, 2014

    Report

    Report Number
    9681684-2014-00032
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS APPEARS TO BE A "MALFUNCTION" TYPE OF EVENT NOT BECAUSE THERE WAS A TECHNICAL MALFUNCTION OF THE DEVICE, BUT DUE TO A USE ERROR THE DEVICE DID NOT PERFORM AS INTENDED. 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
    298659 MAXI 500 FSA ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1