BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 4143528 · Received September 3, 2014

    Report

    Report Number
    1419652-2014-00230
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE PT'S TRANSFER FROM THE WHEELCHAIR TO THE BED, ONE OF THE SLING CLIPS DETACHED FROM THE SPREADER BAR DUE TO INCORRECT SLING INSTALLATION OF THE SLING PROVIDED BY THE CAREGIVER. AS A RESULT, THE PT FELL DOWN AND RECEIVED HEAD TRAUMA BUT NO BLEEDING OR FRACTURE OCCURRED. FROM THE INFORMATION RECEIVED IT WAS INDICATED THAT THE PT'S INJURY WAS NOT SERIOUS AND THAT THE PT WAS HOSPITALIZED ONLY DUE TO OLD AGE AND JUST FOR PREVENTIVE ACTION, WITHOUT ANY TREATMENT OR CONSEQUENCES. IT WAS ALSO INDICATED THAT "THE EVENT WAS NOT RELATED TO PRODUCT DEFICIENCY." MFR REF# 9611530-2014-00067.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535915 MAXI MOVE FSA ARJO MED AB LTD KRA0300

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization