BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER LIFT

    MDR report key: 16572323 · Received March 20, 2023

    Report

    Report Number
    3009402404-2023-00010
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    February 14, 2023
    Report Date
    March 16, 2023
    Manufacturer
    APEX HEALTHCARE MFG. INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMTION 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 PER THE END USER THAT THE PATIENT FELL. NO DESCRIPTION OR WITNESS OF THE FALL WAS GIVEN WHEN END USER CALLED JOERNS TO REPORT. PATIENT WAS TAKEN TO HOSPITAL AND STATED THAT NO SERIOUS INJURY OCCURRED. COMPLAINT #:(B)(4). AND RA#: (B(4) WAS ENTERED INTO OUR SYSTEM TO GET THE PRODUCTS BACK FOR INVESTIGATION. AS OF THIS WRITING, THE PRODUCTS HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953355 HOYER LIFT HOYER PRESENCE FSA APEX HEALTHCARE MFG. INC HOY-6PTWSC-LP

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other