BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERGOLIFT

    MDR report key: 3111062 · Received April 19, 2013

    Report

    Report Number
    9681684-2013-00035
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH INC ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). THE DEVICE WILL BE INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SVC UNIT SUBSIDIARY DIV, NOT AS 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

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170731 ERGOLIFT MANUFACTURED FLOOR PASSIVE LIFT FSA ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1