BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITTLE WAVE FLIP

    MDR report key: 16035057 · Received December 22, 2022

    Report

    Report Number
    3005905321-2022-00006
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    November 23, 2021
    Report Date
    December 1, 2021
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    LBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    USER AND WHEELCHAIR WERE BEING TRANSPORTED IN TAXI, USING THE TRANSPORTATION BRACKETS. DURING THE JOURNEY, THE HUB OF THE WHEEL FAILED AND THE USER WAS PROPELLED INTO THE SIDE OF THE TAXI INTERIOR. USER HAS SUFFERED A CONCUSSION AS A RESULT OF THE INCIDENT. INCIDENT REPORT WAS COMPLETED AND IS ON RECORD. CUSTOMER IS UNSURE AT THIS TIME AS IT'S NOT CLEAR THE WHEEL ALREADY HAD EXISTING DAMAGE OR WAS CRACKED ALREADY WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727039 LITTLE WAVE FLIP ADAPTIVE STROLLER LBE KI MOBILITY, LLC FLIP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other