BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MY01 CONTINUOUS COMPARTMENTAL PRESSURE MONITOR

    MDR report key: 12708197 · Received October 27, 2021

    Report

    Report Number
    3017398927-2021-00001
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    September 17, 2021
    Report Date
    September 28, 2021
    Manufacturer
    MY01 INC.
    Product Code
    LXC
    PMA / PMN Number
    K210525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    THIS WAS REPORTED BY THE MY01 CLIENT SUCCESS CONSULTANT WHO WAS PRESENT DURING THE INCIDENT: MY01 CONTINUOUS COMPARTMENTAL PRESSURE MONITOR WAS BEING USED ON A PATIENT TO MONITOR THEIR COMPARTMENT PRESSURE. THE PHYSICIAN INSERTED THE DEVICE WITH EASE, WITHOUT THE USE OF A LOCAL ANESTHETIC (PHYSICIAN'SCHOICE). SOME TIME AFTER INSERTION, THE PATIENT FELL UNCONSCIOUS FOR A FEW SECONDS. THE PHYSICIAN AND NURSING STAFF WERE AVAILABLE ANDIMMEDIATELY CARED FOR THE PATIENT. THE PATIENT WOKE UP WITHIN SECONDS AND WAS EXAMINED, THE HEALTH-CARE TEAM DEEMED THEM TO BE IN GOODHEALTH. THE DEVICES WERE SUBSEQUENTLY REMOVED AND DISPOSED AT THEFACILITY.DURING THEIR INTERACTION WITH THE PHYSICIAN, THE PATIENT MENTIONED THATTHEY WERE UNCOMFORTABLE AROUND NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605228 MY01 CONTINUOUS COMPARTMENTAL PRESSURE MONITOR MY01 DEVICE LXC MY01 INC. MY01-0001 9449844

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other