BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER PRESENCE

    MDR report key: 7946233 · Received October 9, 2018

    Report

    Report Number
    3010605276-2018-00007
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    June 7, 2018
    Report Date
    June 15, 2018
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3. THE FACILITIES MAINTENANCE REPAIRED THE LIFT PRIOR TO NOTIFYING HTE MANUFACTURER OF THE INCIDENT. COMPLAINT#2018004 HAS BEEN ENTERED INTO OUR SYSTEM. THIS LIFT HAS NOT YET RETURNED AS OF THIS WRITING.

    Description of Event or Problem · 0

    WE RECEIVED THE MDR EVENT FROM OUR USA CUSTOMER AND IT STATED AS BELOW: IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "A FALL THAT THEY HAD WHILE USING A HOYER PRESENCE." UPON SPEAKING TO THE FACILITY, THE RESIDENT FELL OUT OF THE SLING WHILE BEING MOVED IN THE LIFT. WHEN THE RESIDENT WAS PICKED-UP, THE STRAP CAM OFF THE CRADLE. THE RESIDENT FELL OUT OF THE SLING BACKWARDS, HEAD FIRST. THE RESIDENT WAS SENT TO THE HOSPITAL VIA 911 AND SUSTAINED A LACERATION TO THE LEFT BACK SIDE OF THE HEAD THAT REQUIRED 8 STAPLES. COMPLAINT#(B)(4) WAS ENTERED INTO (B)(6) SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788527 HOYER PRESENCE ELECTRIC PATIENT LIFT, FSA APEX HEALTH CARE MFG., INC. HOY-PRESENCE-S

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization