BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIAMI J COLLAR

    MDR report key: 5461746 · Received February 25, 2016

    Report

    Report Number
    2085446-2016-00002
    Event Type
    Injury
    Date Received
    February 25, 2016
    Report Date
    March 16, 2016
    Manufacturer
    OSSUR
    Product Code
    IQK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PLACED IN A MIAMI JTO NECK COLLAR DUE TO TRAUMATIC INJURY. THE PATIENT DEVELOPED ULCERS ALONG THE JAW LINE WITHIN 24 HOURS OF WEARING THE COLLAR. THE INITIAL ULCER REPORTED WAS OFF LOADED BY THE HOSPITAL BY ADDING/CHANGING THE PADDING CONFIGURATION.

    Description of Event or Problem · 1

    PATIENT WAS PLACED IN A MIAMI JTO NECK COLLAR DUE TO TRAUMATIC INJURY. THE PATIENT DEVELOPED ULCERS ALONG THE JAW LINE WITHIN 24 HOURS OF WEARING THE COLLAR. THE INITIAL ULCER REPORTED WAS OFFLOADED BY THE HOSPITAL BY ADDING/CHANGING THE PADDING CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116039 MIAMI J COLLAR ORTHOSIS, CERVICAL IQK OSSUR MJ-400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention