BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDICARE CARINA 350EM

    MDR report key: 11631496 · Received April 7, 2021

    Report

    Report Number
    3007802293-2020-00024
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    November 5, 2020
    Report Date
    April 7, 2021
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY INCORRECTLY SUBMITTED UNDER EXEMPTION #E2015025, WHICH WAS REVOKED EFFECTIVE JUNE 30, 2019. THE REQUEST FOR CORRECTION WAS MADE BY MR. (B)(6), MDR PROGRAM EXPERT AT FDA. (B)(4) IS NOW SUBMITTING THIS REPORT AS THE IMPORTER TO CORRECT THE ORIGINAL ERROR.

    Description of Event or Problem · 1

    CLIENT WAS BEING LIFTED BY THE CARINA 350EM AND WAS SUSPENDED FOR ABOUT 1 MINUTE BEFORE THE CLIENT WAS MOVED. ONCE CAREGIVERS STARTED TO MOVE THE CLIENT, THE CONNECTION POINT BETWEEN THE CLEVIS PIN AND THE BOOM FAILED AND THE CLIENT FELL. CLIENT'S HEAD HIT THE LEG OF THE CARINA AND WAS BLEEDING. CLIENT WAS ATTENDED BY EMS AND WAS HOSPITALIZED FOR 1 DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524473 HANDICARE CARINA 350EM FLOOR LIFT FSA HANDICARE AB 350EM

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization