BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED CARE

    MDR report key: 22420602 · Received July 7, 2025

    Report

    Report Number
    MW5172366
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 1, 2025
    Manufacturer
    HANDICARE USA INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HOYER SLING NOT PROPERLY SECURED; 1 STRAP WAS NOT FULLY HOOKED WHICH RESULTED IN THE RESIDENT SLIPPING OUT OF THE UNSECURED SIDE OF THE SLING AND FALLING ONTO THE FLOOR HITTING HER HEAD ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176423 MED CARE LIFT, PATIENT, NON-AC-POWERED FSA HANDICARE USA INC 400001

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Female Other