BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIAMI OCCIAN JR.

    MDR report key: 7780251 · Received August 14, 2018

    Report

    Report Number
    7780251
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 8, 2018
    Manufacturer
    OSSUR AMERICAS, INC
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE OCCIAN JR® BACK THAT IS DESIGNED TO FIT THE MIAMI ]R® P2 & PL FRONT DOESN'T ACTUALLY FIT THE P1 APPROPRIATELY. CONSEQUENTLY WE DON'T USE THE P1 FRONT SINCE IT DOES NOT PROVIDE STABILITY AND ADEQUATE SKIN PROTECTION FOR C-SPINE PATIENTS. THIS IS A MANUFACTURER DESIGN FLAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623624 MIAMI OCCIAN JR. ORTHOSIS, CERVICAL IQK OSSUR AMERICAS, INC MX170731

    Patients

    Seq Age Sex Outcome Treatment
    1