BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDEO GUIDED CATHETER

    MDR report key: 3231907 · Received December 7, 2012

    Report

    Report Number
    1062474-2012-00003
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    April 28, 2011
    Report Date
    December 7, 2012
    Manufacturer
    MYELOTEC, INC.
    Product Code
    HRX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT REPORT (B)(4) THROUGH MEDWATCH REVEALED NO SPECIFIC INFO REGARDING THE DEVICE WITH THE EXCEPTION OF THE NAME OF DEVICE - VIDEO GUIDED CATHETER. THIS NAME APPLIES TO SEVERAL PRODUCT REFERENCE CATALOG NUMBERS THAT ARE MARKETED AND SOLD BY MYELOTEC, INC. THE DEVICE AS NOT REC'D FOR EVALUATION. SPECIFIC CIRCUMSTANCES SURROUNDING THE EVENT WAS NOT REC'D IN ORDER TO FACILITATE AN EVALUATION. IF ADD'L INFO IS REC'D, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    VOLUNTARY PT REPORT (B)(4) ALLEGES, IN PART, THAT THIS PT HAD SURGERY FOR HERNIATED DISC AND CLAIMS THAT THE SURGEON WAS INCOMPETENT AS HE TRIED TO USE A VIDEO GUIDED CATHETER (MYELOTEC, INC DEVICE NAME) WITH LASER THAT IS NOT APPROVED WITH THE DEVICE. THE INJURIES FOLLOWING THE SURGERY WERE REPORTED BY PT AS "FRIED NERVES", PAIN, NUMBNESS IN LEFT FOOT, RECURRENT DISC HERNIA, DISABILITY, LOSS OF ENJOYMENT OF LIFE, AND SHE IS CRIPPLED FOR LIFE. THE PT ALLEGES THAT SHE HAS BEEN ADVISED BY A NEUROSURGEON THAT SHE NEEDS A TOTAL SPINE FUSION AND A NERVE CONDUCTION STUDY REVEALS COMPLETE NERVE DAMAGE IN HER LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIDEO GUIDED CATHETER CATHETER W/ENDOSCOPE HRX MYELOTEC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other