BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILD DEVICE KIT

    MDR report key: 2762014 · Received September 21, 2012

    Report

    Report Number
    3006450448-2012-00003
    Event Type
    Injury
    Date Received
    September 21, 2012
    Date of Event
    August 17, 2012
    Report Date
    September 21, 2012
    Manufacturer
    VERTOS MEDICAL
    Product Code
    HRX
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF LOW PLATELET COUNT UNDERWENT PERCUTANEOUS DECOMPRESSION WHICH WAS INDICATED FOR TREATMENT OF SYMPTOMATIC CENTRAL CANAL STENOSIS. MIDAZOLAM AND FENTANYL WERE USED TO INDUCE LIGHT SEDATION WITH PATIENT CONVERSANT THROUGHOUT PROCEDURE. NO ABNORMAL BLEEDING WAS NOTED DURING OR AFTER TREATMENT. SUBSEQUENT TO TRANSIENT NUMBNESS IN ONE FOOT AND THEN PERSISTENT NUMBNESS IN HIS OTHER FOOT WITHIN THE FIRST HOUR POST-TREATMENT, HE WAS ADMITTED TO THE HOSPITAL. URINARY RETENTION AND LOW BACK PAIN DEVELOPED THE EVENING OF ADMISSION ON (B)(6) 2012. THE NEXT DAY CT SCAN AND MRI REVEALED A LUMBAR EPIDURAL HEMATOMA (L1-L5). HEMATOMA EVACUATION WAS PERFORMED (B)(6) 2012. ON (B)(6) 2012 THE PATIENT WAS MOBILE AND HAD RESUMED A NORMAL DIET. HE WAS TRANSFERRED TO A SHORT TERM REHAB FACILITY, BUT WAS HOME DOING WELL AND AMBULATING UNAIDED WITH NO REPORTED SEQUELAE BY (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILD DEVICE KIT MILD HRX VERTOS MEDICAL MDK-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization