BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER HPL402

    MDR report key: 6901318 · Received September 28, 2017

    Report

    Report Number
    3010605276-2017-00003
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    August 16, 2017
    Report Date
    September 27, 2017
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GREEN MESH SLING WITH BLACK STRAPS AND BANDING, SIZE LARGE, WAS USED WITH THE LIFT DURING THE INCIDENT. THE SLING IS ABSENT OF ANY LABEL TO IDENTIFY THE MANUFACTURER, BRAND OR PRODUCT NUMBER. APEX HEALTH CARE MFG., INC, NEVER CONTAINED THE SLING WHEN THE LIFT DISPATCHED FROM (B)(4).

    Description of Event or Problem · 1

    WE RECEIVED THE MEDWATCH FORM 3500A FROM OUR CUSTOMER: (B)(6) ON (B)(6) 2017 AND IT STATED AS BELOW: IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, THE CNA'S PUT THE RESIDENT IN THE SLING ON THE BED. THE PATIENT WAS RAISED OFF THE BED AND THE LIFT WAS MOVED. THE RESIDENT SLID OUT OF THE SLING, FEET FIRST. THE RESIDENT LANDED ON THE FLOOR. THE RESIDENT SUSTAINED A HEMATOMA ON THE BACK OF THE HEAD. AROUND 6:30 PM THAT DAY, PATIENT STARTED VOMITING. DOCTOR WAS NOTIFIED AND STAFF SHOULD CONTINUE TO MONITOR. PATIENT CONTINUED TO VOMIT AND WAS SENT TO THE HOSPITAL ON (B)(6) 2017 AT 10:08 AM. CT-SCAN, UA AND LABS WERE DONE. THE RESULTS WERE NORMAL. AS OF THIS WRITING, NOT YET OBTAINED ANY UPDATE NEWS FOR THIS LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680180 HOYER HPL402 PATIENT LIFT, PRODUCT CODE: FSA FSA APEX HEALTH CARE MFG., INC. HPL402

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization