BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 10855005 · Received November 17, 2020

    Report

    Report Number
    3006450448-2020-00002
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 23, 2020
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MILD PROCEDURE WAS PERFORMED ON THE PATIENT ON (B)(6) 2020. AN EPIDUROGRAM WAS ADMINISTERED, AND THE PATIENT WAS TREATED BILATERALLY. NO ISSUES AROSE DURING THE CASE. ON 10/23/2020, THE PHYSICIAN REPORTED TO A COMPANY REPRESENTATIVE THAT THE PATIENT HAD EXPERIENCED OOZING FROM THE TREATMENT SITE, AND ISSUES WITH LOWER LIMB FUNCTIONALITY 7-10 DAYS POST PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND A LUMBAR DECOMPRESSION WAS PERFORMED TO TREAT AN APPARENT EPIDURAL HEMATOMA. AT THE TIME THE INCIDENT WAS REPORTED, THE PATIENT'S LOWER LIMB ISSUES HAD NOT SUBSIDED. NO FURTHER INFORMATION HAS BEEN REPORTED, AS THE PATIENT IS NO LONGER IN CONTACT WITH THE TREATING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320393 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention