BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIAMI J SELECT COLLAR SET

    MDR report key: 23187757 · Received October 1, 2025

    Report

    Report Number
    23187757
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 26, 2025
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A PATIENT WHO WAS WEARING A MIAMI J CERVICAL COLLAR DEVELOPED AN UNSTAGEABLE HOSPITAL ACQUIRED PRESSURE INJURY ON THE RIGHT CLAVICLE DUE TO THE HARD PLASTIC EDGE OF THE COLLAR PRESSING INTO THE PATIENT¿S SKIN. THE PADDING ON THE INSIDE OF THE COLLAR DID NOT COME THE WHOLE WAY DOWN TO THE BOTTOM OF THE COLLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154398 MIAMI J SELECT COLLAR SET ORTHOSIS, CERVICAL IQK OSSUR AMERICAS MX250217

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Other