BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDIS ZEPHYR VASCULAR COMPRESSION BAND

    MDR report key: 18216265 · Received November 28, 2023

    Report

    Report Number
    18216265
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    September 20, 2023
    Report Date
    September 29, 2023
    Manufacturer
    SEMLER TECHNOLOGIES, INC.
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT FOUND TO HAVE SMALL AMOUNT OF BLEEDING AND HEMATOMA FROM RIGHT RADIAL WRIST, APPROXIMATELY 4 HOURS POST REMOVAL OF CORDIS ZEPHYR VASCULAR COMPRESSION BAND. MANUAL PRESSURE APPLIED FOR 10 MINUTES. HEMATOMA DISSIPATED. NO ADDITIONAL TREATMENT PROVIDED. NO FURTHER PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537559 CORDIS ZEPHYR VASCULAR COMPRESSION BAND CLAMP, VASCULAR DXC SEMLER TECHNOLOGIES, INC. 190102

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA Unknown