BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER HPL402

    MDR report key: 7946234 · Received October 9, 2018

    Report

    Report Number
    3010605276-2018-00010
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    July 27, 2018
    Report Date
    October 5, 2018
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT# 2018009 WAS ENTERED INTO OUR SYSTEM.

    Description of Event or Problem · 0

    WE RECEIVED THIS 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, "HEMODIALYSIS PATIENT ARRIVED FOR SCHEDULED DIALYSIS TREATMENT. PATIENT ARRIVED VIA WHEELCHAIR WITH NURSING HOME JOERNS MESH SLING UNDERNEATH PATIENT. UPON TRANSFERRING PATIENT FROM WHEELCHAIR TO DIALYSIS CHAIR UTILIZING DIALYSIS FACILITY JOERNS HOYER LIFT DEVICE, THE SLING LOOPS RIPPED APART FROM THE MESH SLING BODY. THE PATIENT LANDED ON THE FLOOR, LANDED ON HIS BACK. PATIENT REMAINED ALERT AND ORIENTED, REPORTED BACK PAIN. 911 WAS CALLED, PATIENT WAS TRANSPORTED TO ER AND ADMITTED TO HOSPITAL. NO FRACTURES REPORTED." UPON SPEAKING WITH THE FACILITY, THE SLING IS BLUE MESH AND OF UNIDENTIFIED MODEL NUMBER OR VENDOR. WHEN THE FACILITY INSPECTED THE SLING AFTER THE INCIDENT, THEY WERE UNABLE TO READ THE LABEL DUE TO THE PRINTED INFORMATION WAS WASHED OUT. THE BROKEN SLING WAS RETURNED TO THE NURSING FACILITY AFTER INCIDENT. COMPLAINT (B)(4) WAS ENTERED INTO JOERNS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788822 HOYER HPL402 ELECTRIC PATIENT LIFT, FSA APEX HEALTH CARE MFG., INC. HPL402

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization