BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA CTO

    MDR report key: 16852689 · Received May 2, 2023

    Report

    Report Number
    16852689
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    March 2, 2023
    Report Date
    April 21, 2023
    Manufacturer
    ASPEN MEDICAL PRODUCTS, LLC
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POSTERIOR HEAD WOUND WAS FOUND ABOVE CTO-BRACE ON OCCIPUT (BACK OF HEAD). WHEN THEY COULD START SITTING HIM UP WITH THE CTO DEVICE, THEY DID. HOWEVER, THE CTO DEVICE HAS A WAIST STRAP AND IF THE PATIENT HAS A LARGER ABDOMEN IT WILL PUSH UP ON THE WHOLE DEVICE INCLUDING ON THE MANDIBLE AND BACK OF THE HEAD. THE PADDING ON THE COLLAR IS NOT PROTECTIVE ENOUGH AND THE HARD PIECE CAN SNEAK OVER THE PADDING. HANGER CLINIC DID COME BACK TO ADJUST THE DEVICE AND PATIENT KEPT TRYING TO TAKE THE BRACE OFF BECAUSE IT WAS SO UNCOMFORTABLE. PHOTOS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247681 VISTA CTO ORTHOSIS, CERVICAL IQK ASPEN MEDICAL PRODUCTS, LLC 984510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other