BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIAMI JR. PEDIATRIC COLLAR

    MDR report key: 6764523 · Received August 3, 2017

    Report

    Report Number
    2085446-2017-00004
    Event Type
    Injury
    Date Received
    August 3, 2017
    Report Date
    November 17, 2017
    Manufacturer
    OSSUR AMERICAS, INC.
    Product Code
    IQK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PEDIATRIC PATIENT WEARING (B)(4) PEDIATRIC COLLAR SUSTAINED A GRADE III SKIN BREAKDOWN IN FRONT CHIN AREA.

    Description of Event or Problem · 1

    PEDIATRIC PATIENT WEARING MIAMI JR. PEDIATRIC COLLAR SUSTAINED A GRADE III SKIN BREAKDOWN IN FRONT CHIN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544653 MIAMI JR. PEDIATRIC COLLAR CERVICAL COLLAR IQK OSSUR AMERICAS, INC. MJ-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention