BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 20292992 · Received September 24, 2024

    Report

    Report Number
    3006450448-2024-00014
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    April 17, 2019
    Report Date
    September 24, 2024
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2019, AN 88 YEAR-OLD MALE PATIENT HAD A MILD PROCEDURE PERFORMED. FOLLOWING THE PROCEDURE, THE PATIENT WENT TO THE HOSPITAL FOR LEG PAIN AND WAS DIAGNOSED WITH AN EPIDURAL HEMATOMA. THE PATIENT WAS TREATED FOR THE INITIAL HEMATOMA, AND THEN AGAIN FOR A SECOND HEMATOMA THAT HAD DEVELOPED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE PATIENT HAS MADE A FULL RECOVERY. THE PHYSICIAN REPORTED THAT THE PATIENT'S HISTORY WAS BELIEVED TO BE THE CAUSE OF THE HEMATOMA, AS THE PATIENT WAS ON BLOOD THINNERS AND WAS REPORTED TO BE SUFFERING FROM ALCOHOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105165 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Required Intervention