BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSSUR MIAMI J SELECT COLLAR

    MDR report key: 15083957 · Received July 22, 2022

    Report

    Report Number
    15083957
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    July 7, 2022
    Report Date
    July 12, 2022
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT WAS PLACED IN A MIAMI J SELECT COLLAR. THE PATIENT WAS EXPERIENCING SWELLING DUE TO INJURY AND SURGERIES. THE INCREASE IN SWELLING ADDED PRESSURE TO BONY PROMINENCES. DESPITE ADJUSTING THE COLLAR TO THE LOWEST POSSIBLE SETTING, THE PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE INJURY ON HER CHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607777 OSSUR MIAMI J SELECT COLLAR ORTHOSIS, CERVICAL IQK OSSUR AMERICAS

    Patients

    Seq Age Sex Outcome Treatment
    1 5110 DA Female Other