BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVA600EE

    MDR report key: 5945273 · Received September 13, 2016

    Report

    Report Number
    3009481053-2016-00005
    Event Type
    Injury
    Date Received
    September 13, 2016
    Date of Event
    June 7, 2016
    Report Date
    July 13, 2016
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HANDICARE AB HAS ASKED THE CLIENT TO PROVIDE ADDITIONAL INFORMATION SURROUNDING THIS EVENT BUT NOT YET RECEIVED A REPLY FROM CLIENT. THE ADDITIONAL INFORMATION SHALL BE USED FOR INVESTIGATING THE CAUSE OF THIS EVENT. NO HEALTH HAZARD EVALUATION (HHE) IS ATTACHED TO THIS MDR REPORT DUE TO INCOMPLETE INFORMATION. HANDICARE AB HAS CONCLUDED THAT NO INFORMATION OF SIGNIFICANCE CAN BE PROVIDED THROUGH AN HHE AT THIS TIME. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE EVA-LIFT WAS USED TO LIFT PATIENT FOR WEIGHING WHEN PATIENT FELL TO THE FLOOR FROM THE SLING. THE PATIENT SUSTAINED A FRACTURE TO HER RIGHT ARM AS WELL AS SKIN TEARS ON RIGHT ARM AND LEFT LEG. THE PATIENT WAS SUBSEQUENTLY BROUGHT TO ER FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597094 EVA600EE LIFT, PATIENT, NON AC-POWERED FSA HANDICARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization