BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIAMI J-400 REGULAR

    MDR report key: 9888259 · Received March 26, 2020

    Report

    Report Number
    MW5093940
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    January 21, 2020
    Report Date
    March 24, 2020
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NECK BRACE IN PLACE ON ADMISSION. REDNESS TO CHIN DOCUMENTED ON ADMISSION, AM OF 1/17 WOUND CARE ASSESSED AS STAGE 2. ON 1/21, RN IDENTIFIED NECK BRACE HAS RAISED CONNECTION AT THE CHIN WHICH IS ABNORMAL FOR NECK BRACE. PROVIDED PATIENT WITH NEW NECK BRACE WITH SMOOTH CONNECTION AND SEQUESTERED ORIGINAL BRACE FOR EXAMINATION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350664 MIAMI J-400 REGULAR ORTHOSIS, CERVICAL IQK OSSUR AMERICAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR