BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILD DEVICE KIT

    MDR report key: 2101509 · Received May 18, 2011

    Report

    Report Number
    3006450448-2011-00002
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 11, 2011
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH HISTORY OF LUMBAR SPINAL STENOSIS AND RECENT FALL WITHIN ONE WEEK OF PROCEDURE WAS TREATED ON (B)(6) 2011 WITH BILATERAL DECOMPRESSION AT L4-5. THE PROCEDURE WAS UNEVENTFUL AND PT WAS DISCHARGED THE SAME DAY. MONDAY (B)(6) 2011, PT COMPLAINED OF LEFT FOOT WEAKNESS, BACK PAIN AND BILATERAL BUTTOCK PAIN. PT WAS ADMITTED TO THE HOSPITAL AND AN MRI PERFORMED. POST-TX MRI RADIOLOGY REPORT REVEALED NO HEMATOMA OR OTHER VISIBLE EXPLANATION FOR EVENT. PT WAS TREATED WITH MEDROL DOSE PACK, MORPHINE PCA, VALIUM IV AND SOMA. NEUROLOGICAL EVALUATION DETERMINED SURGICAL INTERVENTION UNWARRANTED. THE PT WAS TRANSFERRED TO A SHORT-TERM REHAB FACILITY. AN EPIDURAL STEROID INJECTION WAS GIVEN ON (B)(6) 2011. ON (B)(6) 2011, THE PT DEMONSTRATED ABILITY TO STAND FROM A SITTING POSITION, TAKE UNASSISTED STEPS AND MOVE AROUND USING A WALKER. BY (B)(6) 2011 PT WAS ABLE TO WALK WITH NO ASSISTANCE AND WAS SUBSEQUENTLY DISCHARGED. THE PHYSICIAN REPORTS PT'S PAIN LOWER THAN PRE-TREATMENT AND PAIN PILL CONSUMPTION AS LITTLE AS NONE PER DAY. PT WAS DISCHARGED FROM FACILITY WITH NO OBSERVED SEQUELAE. EVENT CAUSE REMAINS UNCLEAR, WITH PT AGE AND RECENT FALL AS CONFOUNDING FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILD DEVICE KIT NONE HRX VERTOS MEDICAL INC. MDK-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization