BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER STATURE

    MDR report key: 7946238 · Received October 9, 2018

    Report

    Report Number
    3010605276-2018-00006
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    April 17, 2018
    Report Date
    April 19, 2018
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT#2018003 ENTERED INTO OUR SYSTEM. THE LIFT HAS NOT YET BEEN RETURNED AS OF THIS WRITING.

    Description of Event or Problem · 0

    WE RECEIVED THE MDR EVENT FROM OUR (B)(6) CUSTOMER AND IT STATED AS BELOW: IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, HOYER STATURE LIFT FAILED AND CRADLE FELL TO FLOOR WITH RESIDENT IN SLING YESTERDAY. RESIDENT WAS INJURED AND WENT TO HOSPITAL BUT IS BACK AT FACILITY. UPON SPEAKING WITH THE FACILITY, IT WAS STATED THAT "RESIDENT WAS TRANSFERRED FROM MOTORIZED WHEELCHAIR TO HER BED. THE MAST FELL AND THE RESIDENT LANDED ON THE FLOOR. RESIDENT WAS IN HOYER SLING. RESIDENT WAS TRANSFERRED VIA 911 TO HOSPITAL TO THE ER FOR EVALUATION. X-RAYS AND CT-SCAN WERE PERFORMED. RESIDENT SUSTAINED BRUISE ON RIGHT SHOULDER, BRUISE TO RIGHT FOREHEAD (RIGHT ABOVE THE EYE) AND BUMP TO THE BACK OF THE HEAD (CENTER OF HEAD). 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
    788816 HOYER STATURE PATIENT LIFT FSA APEX HEALTH CARE MFG., INC. HOY-STATUREWSC

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization