BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWIFTHOOK

    MDR report key: 10275467 · Received July 15, 2020

    Report

    Report Number
    3009481053-2020-00012
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 15, 2020
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CODES ARE NOT ABLE TO BE INPUTTED VIA ESUBMITTER. I AM WORKING WITH ESUBMITTER SUPPORT TO RECTIFY THIS ISSUE. IN THE MEANTIME, THEY ARE LISTED BELOW: (B)(4).

    Description of Event or Problem · 1

    WHEN LIFTING THE PATIENT IN THE MORNING, THE SLING BAR DETACHED AND THE PATIENT LANDED ON THE FLOOR. THE PATIENT HAS GOT SEVERAL BRUISES AND PAIN IN THE TAILBONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743454 SWIFTHOOK PATIENT LIFT FSA HANDICARE AB 70200008

    Patients

    Seq Age Sex Outcome Treatment
    1