BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER LIFT

    MDR report key: 20163529 · Received September 6, 2024

    Report

    Report Number
    3009402404-2024-00037
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    July 26, 2024
    Report Date
    September 6, 2024
    Manufacturer
    APEX HEALTHCARE MFG. INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE , ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER THAT CNA REPORTS THAT POST SHOWER HE/SHE WAS ATTEMPTING TO TRANSFER RESIDENT USING JOERN HOYER ELEVATE LIFT WITH JOERNS DELUXE STAND AID SLING FROM SHOWER CHAIR TO WHEELCHAIR. RESIDENT BEGAN TO YELL AND DEMONSTRATE BEHAVIORS AND BEGAN TO SLIDE OUT OF LIFT SLING. CAN REPORT HE/ SHE AND A SECOND CAN ASSISTED THE RESIDENT TO THE FLOOR. COMPLAINT #(B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234844 HOYER LIFT PATIENT LIFT FSA APEX HEALTHCARE MFG. INC HOY-ELEVATE-S

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Other