BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI 500

    MDR report key: 3841258 · Received May 20, 2014

    Report

    Report Number
    1419652-2014-00135
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE PATIENT'S TRANSFER FROM THE WHEELCHAIR USING THE MAXI 500 LIFT DEVICE AND THE CLIP SLING, THE LEFT LEG CLIP DETACHED FROM THE HANGER BAR OF THE LIFT WHEN THE PATIENT WAS OFF THE WHEELCHAIR AND WHEN THE HANGER BAR WAS PUSHED DOWN TO LEVEL THE PATIENT. THE PATIENT'S FACE HIT THE HANGER BAR OF THE LIFT. THEN THE LIFT WAS LOWERED TO THE CHAIR. THE PATIENT RECEIVED BRUISES AND CONTUSION TO THE FACIAL AREA ON THE LEFT SIDE OF THE FACE AS A CONSEQUENCE OF THE EVENT. THEN THE PATIENT WAS MONITORED BUT NOT HOSPITALIZED. REF MFR REPORT 9681684-2014-00032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298661 MAXI 500 FSA ARJOHUNTLEIGH MAGOG INC. KM560181

    Patients

    Seq Age Sex Outcome Treatment
    1 Other