BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMOVE (OLD)

    MDR report key: 2647597 · Received July 6, 2012

    Report

    Report Number
    9611530-2012-00088
    Event Type
    Injury
    Date Received
    July 6, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 6, 2012
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC.(B)(4) ON BEHALF OF THE MANUFACTURER ARJO (B)(4). PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MANUFACTURED, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO (B)(4). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO (B)(4) AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION # (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2012: DURING THE TRANSFER OF THE PATIENT FROM THE BED TO THE WHEELCHAIR, ONE OF THE CLIPS OF THE SLING IS UNHOOKED, SO THE PATIENT FELL DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMOVE (OLD) NONE FSA ARJO MED AB LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other