BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 17337389 · Received July 17, 2023

    Report

    Report Number
    3006450448-2023-00005
    Event Type
    Injury
    Date Received
    July 17, 2023
    Date of Event
    May 19, 2023
    Report Date
    July 17, 2023
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6), A PATIENT HAD THE MILD PROCEDURE AT THE BILATERAL L1-L2 AND L2-L3 WITH NO EPIDUROGRAM. IT WAS REPORTED THAT TWO DAYS FOLLOWING THE PROCEDURE ON (B)(6) THE PATIENT HAD INCREASED PAIN GOING DOWN TO THE KNEES AFTER RESUMING THEIR BLOOD THINNER MEDICATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) WITH LEG WEAKNESS AND TROUBLE WALKING AND WAS DIAGNOSED WITH AN EPIDURAL HEMATOMA. HE WAS ADMITTED TO THE HOSPITAL, AND A SURGICAL HEMATOMA EVACUATION WAS PERFORMED AT T12-L1. THE PATIENT WAS DISCHARGED ON (B)(6) AND DID NOT GO TO THE MILD FOLLOW UP APPOINTMENT AND HAS NOT SPOKEN TO THE MILD PHYSICIAN OR HIS TEAM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616836 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention