BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C625 MANUAL TRAVERSE

    MDR report key: 12235037 · Received July 27, 2021

    Report

    Report Number
    3007802293-2021-00007
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    July 5, 2021
    Report Date
    July 27, 2021
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    UDI-DI
    00810045510484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    A SENIOR ACCOUNT EXECUTIVE OF HANDICARE WENT TO THE FACILITY ON 7JULY2021 TO INSPECT THE LIFT. UPON INSPECTION OF THE LIFT AND CARRY BAR, NO VISIBLE DEFECTS WERE FOUND. THE LIFT WAS FULLY OPERATIONAL IN NORMAL CONDITION WITH NO ISSUES. THE SLING WAS NOT PRESENT BUT A SPH COORDINATOR OF THE FACILITY STATED THE SLING WAS FOUND TO BE IN GOOD CONDITION WITH NO DEFECTS, TEARS OR STITCHING INTEGRITY ISSUES. THIS INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN COMPLETE.

    Description of Event or Problem · 1

    PATIENT WAS BEING TRANSFERRED OUT OF AVERO MOTION BATH WHEN THE SHOULDER ATTACHMENT OF THE SLING RELEASED FROM THE BULL HORN CARRY BAR OF A C625 OVERHEAD LIFT. THE PATIENT FELL AND BROKE HIS HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129682 C625 MANUAL TRAVERSE CEILING LIFT FSA HANDICARE USA INC. 323117 00810045510484

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization