BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDICARE EVA450EE HOYER

    MDR report key: 16583473 · Received March 20, 2023

    Report

    Report Number
    MW5115870
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    November 12, 2022
    Report Date
    March 16, 2023
    Manufacturer
    DIRECT HEALTHCARE GROUP SVERIGE AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SNAP ON HANDICARE EVA450EE CAME UNDONE, LET SLING LOOSE, DROPPING RESIDENT WHO HIT MOUTH ON BASE OF HOYER, BREAKING UPPER DENTURE, HIT HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999316 HANDICARE EVA450EE HOYER LIFT, PATIENT, NON-AC-POWERED FSA DIRECT HEALTHCARE GROUP SVERIGE AB EVA 450EE 2022/06-ST

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Hospitalization