BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN VISTA COLLAR

    MDR report key: 7689417 · Received July 16, 2018

    Report

    Report Number
    7689417
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 15, 2018
    Manufacturer
    ASPEN MEDICAL PRODUCTS
    Product Code
    IQE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRAUMA PATIENT IN C-COLLAR FOR EXTENDED PERIOD OF TIME, DEVELOPED PRESSURE INJURIES TO THE OCCIPITAL AREA OF POSTERIOR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532200 ASPEN VISTA COLLAR SPINAL ORTHOTICS IQE ASPEN MEDICAL PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other