BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDEPENDENT LIFTER

    MDR report key: 7143023 · Received December 22, 2017

    Report

    Report Number
    3007802293-2017-00110
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    April 21, 2017
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOME OF INVESTIGATION PENDING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    INDIVIDUAL USING THE INDEPENDENT LIFTER HAD THE LEG SUPPORTS SLIP FROM UNDER BOTH LEGS AS THEY WERE BEING LIFTED UP. IN AN ATTEMPT TO LOWER THEMSELF DOWN THEY FELL TO THE FLOOR. THEY REPORTED HAVING FRACTURES TO THE FOLLOWING AREAS: LEFT HIP, LEFT TIBIA, LEFT FOOT, LEFT PINKY TOE, AND RIGHT FIBULA. THE PATIENT HAS OSTEOPOROSIS AND WENT TO THE HOSPITAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923119 INDEPENDENT LIFTER INDEPENDENT LIFTER FSA HANDICARE USA INC. 753986

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization