BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 16599734 · Received March 23, 2023

    Report

    Report Number
    3006450448-2023-00002
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    January 26, 2023
    Report Date
    May 24, 2023
    Manufacturer
    VERTOS MEDICAL, INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 2/22/2023, A VERTOS REPRESENTATIVE WAS INFORMED BY A PHYSICIAN THAT A FEMALE PATIENT, WHO HAD THE MILD PROCEDURE ON (B)(6) 2023, WAS DIAGNOSED WITH A HEMATOMA. THE MILD PROCEDURE WAS UNDER IV MAC SEDATION AND NO EPIDUROGRAM WAS USED. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE IFU AND PHYSICIAN TRAINING. THE VERTOS REPRESENTATIVE WAS NOT PRESENT DURING THIS PROCEDURE. IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH A HEMATOMA THE FOLLOWING DAY. THE HEMATOMA WAS AT THE SAME LEVEL AS THE MILD PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DECOMPRESSION (LAMINECTOMY) WAS PERFORMED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED FOLLOWING THE LAMINECTOMY AND IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A VERTOS REPRESENTATIVE WAS INFORMED BY A PHYSICIAN THAT A FEMALE PATIENT HE HAD PERFORMED A MILD PROCEDURE ON WAS DIAGNOSED WITH A HEMATOMA. THE MILD PROCEDURE WAS UNDER IV MAC SEDATION AND NO EPIDUROGRAM WAS USED. THE VERTOS REPRESENTATIVE WAS NOT PRESENT DURING THIS PROCEDURE AND DETAILS OF THE EVENTS AS WELL AS THE DATE OF THE MILD PROCEDURE ARE CURRENTLY UNKNOWN DUE TO THE PHYSICIAN BEING ON A THREE-WEEK VACATION AFTER INITIALING REPORTING THIS EVENT TO THE VERTOS REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596795 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL, INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention