BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER LIFT

    MDR report key: 18340719 · Received December 15, 2023

    Report

    Report Number
    3009402404-2023-00047
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 10, 2023
    Report Date
    December 15, 2023
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, 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 PATIENT FELL HEAD FIRST OUT OF SLING ON PATIENT LIFT MODEL HPL700, USING AN EXTRA LARGE LOOP 2020 DESIGN LOOP SLING FULLBACK, DISPOSABLE. IT IS NOTED AND PICTURES PROVE THAT THE SLING USED ON THE LIFT WAS NOT A JOERNS MANUFACTURED SLING. COMPLAINT # (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929680 HOYER LIFT PATIENT LIFT FSA JOERNS HEALTHCARE HPL700NA1010P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other