BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERA

    MDR report key: 4113940 · Received August 25, 2014

    Report

    Report Number
    9681684-2014-00056
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 12, 2014
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJOHUNTLEIGH MAGOG INC. ON BEHALF OF THE IMPORTER (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT THE RESIDENT FELL OUT OF THE SLING DURING THE TRANSFER USING OPERA LIFT DEVICE. FROM THE INFORMATION RECEIVED THE RESIDENT RECEIVED HEAD INJURIES AS A CONSEQUENCE OF THE EVENT AND WAS SENT TO HOSPITAL FOR TREATMENT - STITCHES TO THE HEAD WERE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512321 OPERA FSA ARJO MED AB LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization