BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER LIFT

    MDR report key: 2323452 · Received October 27, 2011

    Report

    Report Number
    2182305-2011-00037
    Event Type
    Injury
    Date Received
    October 27, 2011
    Date of Event
    September 11, 2011
    Report Date
    October 24, 2011
    Manufacturer
    APEX HEALTHCARE MFG. INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO (B)(4) MEDICAL (B)(4) INC. BY THE DEALER WHO SUPPLIED THE LIFT TO THE HOME OF THE END USER. FAMILY MEMBERS WERE TRAINED BY AN OCCUPATIONAL THERAPIST IN THE PROPER MANNER OF PERFORMING A LIFT. THE PT [HOME USER WAS BEING CARED FOR IN THEIR HOME UPON RETURN FROM THE HOSPITAL AND THIS IS WHERE THE LIFTER WAS BEING USED. IT WAS REPORTED THAT THERE WAS AN INCIDENT WITH THE LIFTER ON (B)(4) 2011 AND THE PT DIED ON (B)(6)2011. THE CAUSE OF THE DEATH IS UNK. IT WAS REPORTED THAT THE PT HAD BROKEN HIS PELVIS AS A RESULT OF A FALL WHILE USING THE LIFTER. THE BASE OF THE MAST HAD BROKEN WHERE IT FIT INTO THE BASE PER THE REPORT. COMPLAINT NUMBER (B)(4) WAS ENTERED INTO THE SYSTEM W/RA# (B)(4) ISSUED TO GET LIFT IN QUESTION BACK FOR IN-HOUSE EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PATIENT LIFTER FNG APEX HEALTHCARE MFG. INC. ADVANCE-E

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death