BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER STATURE

    MDR report key: 6913954 · Received October 4, 2017

    Report

    Report Number
    3009402404-2017-00046
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 4, 2017
    Manufacturer
    APEX HEALTHCARE MFG INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND ANY 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 · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, STAFF WAS LIFTING THE PATIENT AND THE LEG OF THE LIFT SNAPPED OFF AND THE PATIENT FELL TO THE FLOOR. THE PATIENT WAS SENT TO THE HOSPITAL AND SUSTAINED A FRACTURED RIGHT HIP. COMPLAINT# (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE LIFT RETURNED TO JOERNS FOR INVESTIGATION. AS OF THIS WRITING, THE LIFT HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693295 HOYER STATURE PATIENT LIFT FSA APEX HEALTHCARE MFG INC HOY-STATUREWSC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization