BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C6 MCOT PPM

    MDR report key: 12686802 · Received October 24, 2021

    Report

    Report Number
    2133409-2021-00002
    Event Type
    Injury
    Date Received
    October 24, 2021
    Date of Event
    October 1, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    PMA / PMN Number
    K153473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED DEVICE WAS NOT RETURNED BY PATIENT/CUSTOMER TO DISTRIBUTOR FOR RETURN TO MANUFACTURER. SKIN IRRITATION IS A KNOWN RISK DESCRIBED IN PATIENT LITERATURE. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC.

    Description of Event or Problem · 1

    CUSTOMER COMMUNICATION OF CONSULTING A HEALTHCARE PROFESSIONAL DUE TO REACTION/SKIN IRRITATION. THE PATIENT'S CLINICIAN ADVISED THEM TO CONSULT A DERMATOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584881 C6 MCOT PPM C6 MCOT PPM, PRODUCT CODE: DSI DSI BRAEMAR MANUFACTURING, LLC UNIT, J3 S 2018, C6M

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other