BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 19047618 · Received April 4, 2024

    Report

    Report Number
    3006450448-2024-00004
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 4, 2024
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A MILD PROCEDURE PERFORMED ON (B)(6) 2024, THE PHYSICIAN OBSERVED CSF LEAKING OUT OF THE MILD PORTAL DEVICE. THE PATIENT'S SPINAL DURA HAD BEEN BREACHED AFTER THE PHYSICIAN HAD UNEXPECTEDLY ADVANCED THE MILD TROCAR DEVICE TOO FAR BY TAPPING THE HANDLE OF THE DEVICE USING HIS PALM, WHICH IS NOT STANDARD PROCEDURE FOR ADVANCING MILD DEVICES IN ACCORDANCE WITH THE PRODUCT IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90301 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention