BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIAMI J COLLAR

    MDR report key: 7116558 · Received December 13, 2017

    Report

    Report Number
    MW5073957
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    December 8, 2017
    Report Date
    December 12, 2017
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROVIDER ORDERED SOFT COLLAR FOR PATIENT DUE TO POTENTIAL NECK TRAUMA IN CASE OF PATIENT WITH ALTERED MENTAL STATUS WITH UNKNOWN ETIOLOGY. I RETRIEVED A COLLAR THAT WAS STILL IN ITS ORIGINAL PACKAGING, WHEN PACKAGING WAS OPENED, IT DID NOT CONTAIN THE FRONT HALF OF THE COLLAR. REMOVED THE COLLAR FROM CIRCULATION AND RETRIEVED ANOTHER (WHICH WAS THE LAST IN STOCK). CREATED SITUATION OF AN UNSAFE CONDITION THAT COULD HAVE SIGNIFICANTLY DELAYED APPLICATION OF A NECESSARY MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891740 MIAMI J COLLAR ORTHOSIS, CERVICAL IQK OSSUR AMERICAS MJP-0871 MX170925

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR