BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDEPENDENT LIFTER

    MDR report key: 7143088 · Received December 22, 2017

    Report

    Report Number
    3007802293-2017-00111
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    April 21, 2017
    Report Date
    October 6, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOME OF INVESTIGATION PENDING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION. THIS REPORT WAS ORIGINALLY SUBMITTED IN DECEMBER 2017. VIJAI D JALADHI NOTIFIED US THAT THE INITIAL REPORT WAS MISSING FOR THIS SUBMISSION ON SEPTEMBER 11, 2020, AND ASKED US TO RESUBMIT THE REPORT WITH "INITIAL" CHECKED OFF (G7).

    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 THEMSELVES 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
    924218 INDEPENDENT LIFTER INDEPENDENT LIFTER FSA HANDICARE USA INC. 753986

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization