BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIAMI J SELECT COLLAR SET

    MDR report key: 22519411 · Received July 16, 2025

    Report

    Report Number
    22519411
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    March 25, 2025
    Report Date
    June 26, 2025
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WEARING THE MIAMI J COLLAR AND DEVELOPED AN UNSTAGEABLE, RIGHT CLAVICLE PRESSURE INJURY. IT WAS NOTICED THAT THE PADDING INSIDE THE COLLAR DID NOT COME DOWN TO THE DISTAL END OF THE COLLAR, SO THERE WAS ONLY PLASTIC ON THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539921 MIAMI J SELECT COLLAR SET ORTHOSIS, CERVICAL IQK OSSUR AMERICAS MJSR-101 MX250217

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other