BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER PRESENCE

    MDR report key: 7946237 · Received October 9, 2018

    Report

    Report Number
    3010605276-2018-00008
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    June 3, 2018
    Report Date
    October 5, 2018
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT # 2018005 WERE ENTERED INTO OUR SYSTEM.

    Description of Event or Problem · 0

    WE RECEIVED THIS 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, "THE STAFF HAD RESIDENT TIN SLING, THEY WERE TRANSFERRING HER FROM BED TO WHEELCHAIR. LIFT GOT STUCK. SHE KEPT TRYING TO PUT IT DOWN. IT ALLEGEDLY STARTED TO TILT. THEY WERE ABLE TO LOWER IT DOWN TO THE FLOOR WITH RESIDENT IN IT. THE FOLLOWING INJURIES ALLEGEDLY OCCURRED: CUT ON HER ARM, FOOT WAS SWOLLEN. THEY DID AN X-RAY , NO FRACTURE. THE PRODUCT HAS BEEN TAKEN OUT OF USE". NUMEROUS REQUESTS TO THIS FACILITY HAVE BEEN MADE TO RECEIVE ADDITIONAL INFORMATION AND DETAILS RELATED TO THIS ALLEGED INCIDENT REPORT WITH NO RESPONSE FROM THE FACILITY. COMPLAINT# (B)(4) WERE ENTERED INTO JOERNS 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
    788529 HOYER PRESENCE ELECTRIC PATIENT LIFT FSA APEX HEALTH CARE MFG., INC. HOY-PRESENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization