BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDICARE QUICKMOVE TRANSFER AID

    MDR report key: 11633753 · Received April 8, 2021

    Report

    Report Number
    3007802293-2020-00026
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    October 16, 2020
    Report Date
    April 7, 2021
    Manufacturer
    HANDICARE AB
    Product Code
    IKX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY INCORRECTLY SUBMITTED UNDER EXEMPTION #E2015025, WHICH WAS REVOKED EFFECTIVE JUNE 30, 2019. THE REQUEST FOR CORRECTION WAS MADE BY MR. (B)(6), MDR PROGRAM EXPERT AT FDA. HANDICARE USA IS NOW SUBMITTING THIS REPORT AS THE IMPORTER TO CORRECT THE ORIGINAL ERROR.

    Description of Event or Problem · 1

    PATIENT WAS GETTING UP WITH A 2 STAFF ASSIST. PATIENT WAS ON THE QUICKMOVE WHEN THE LEFT LEG BROKE CAUSING THE PATIENT TO FALL TO THE FLOOR. PATIENT SUFFERED LEFT HIP PAIN AND A LEFT GLUTEAL ABRASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535002 HANDICARE QUICKMOVE TRANSFER AID TRANSFER AID IKX HANDICARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other