BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCUL8 PRO

    MDR report key: 13865375 · Received March 23, 2022

    Report

    Report Number
    3014676071-2022-00001
    Event Type
    Injury
    Date Received
    March 23, 2022
    Date of Event
    January 19, 2022
    Report Date
    February 17, 2022
    Manufacturer
    ORTHO8 INC.
    Product Code
    JOW
    UDI-DI
    00194832000021
    PMA / PMN Number
    K212731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DID NOT FIND ANYTHING WRONG WITH UNITS, APPEAR TO OPERATE AS DESIGNED. THE FOLLOWING WERE COMPLETED: ONE DC BARREL JACK SHOWED SOME SIGNS OF BENDING, DID CONFIRM BARREL JACK STILL WORKING OK. VISUAL REVIEW OF BOTH UNITS DID NOT SHOW ANY SIGNS OF MARKS OR DAMAGE TO BOTH UNITS AND WRAPS. VISUAL INSPECTION - INSIDE WRAPS SHOW NO MARKS OR DAMAGE AND SMOOTH, NO EXTRANEOUS OBJECTS BOTH UNITS POWERED UP WITH GREEN STATUS LED AND PUMP CYCLE APPEARS NORMAL. 3 FULL PUMP CYCLES APPEAR OK ON BOTH UNITS, UNITS TESTED BY WRAPPING "WRAP" BACK ON ITSELF. BOTH UNITS APPEAR TO CHARGE BATTERY WHEN DC CHARGER IS PLUGGED IN.

    Description of Event or Problem · 0

    HEMATOMA FORMED ON THE RIGHT LEG UNDER THE COMPRESSION SLEEVE. THE ATTENDING PHYSICIAN HAD TO DRAIN THE HEMATOMA AND CHANGE THE PATIENT'S ANTICOAGULANT MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797143 CIRCUL8 PRO DVT PREVENTION DEVICE JOW ORTHO8 INC. 08-0027 CP0821072001 00194832000021

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention