BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2853091 · Received July 11, 2012

    Report

    Report Number
    1062474-2012-00002
    Event Type
    Injury
    Date Received
    July 11, 2012
    Date of Event
    June 2, 2010
    Report Date
    July 11, 2012
    Manufacturer
    MYELOTEC, INC.
    Product Code
    HRX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INFORMATION ON THE DEVICE TYPE, LOT NUMBER, SERIAL NUMBER WAS NOT PROVIDED. THE PETITION ALSO DOES NOT PROVIDE ANY INFORMATION ON OTHER DEVICES USED CONCURRENTLY. THE DEVICE(S) ALLEGED TO HAVE BEEN USED WERE NOT RETURNED TO MYELOTEC FOR EVALUATION AND INVESTIGATION.

    Description of Event or Problem · 1

    ANNULAR TEAR; DURAL PUNCTURE; RIGHT LOWER EXTREMITY PAIN; WEAKNESS IN RIGHT FOOT AND LEG. THIS EVENT ARISES FROM A LAWSUIT FILED AGAINST TREATING PHYSICIANS, OPERATING SURGEONS, EMPLOYER/FACILITIES, AND RELATED HEALTHCARE PROVIDERS. THE LAWSUIT REFERS TO A FEMALE PATIENT THAT UNDERWENT A PROCEDURE HER PHYSICIANS REFERRED TO AS "EPIDURAL LASER DISCECTOMY" OR "ACCURASCOPE." PLAINTIFF'S COUNSEL CONTENDS THE HEALTHCARE PROVIDER DEFENDANTS UTILIZED UNSPECIFIED MYELOTEC PRODUCTS IN THE SUBJECT SURGERY. THE PATIENT'S PRE-OPERATIVE MEDICAL HISTORY INCLUDED DIAGNOSES OF LUMBAR HERNIATED NUCLEUS PULPOSUS; LUMBAR RADICULOPATHY; LUMBAR DEGENERATIVE DISK DISEASE; AND LUMBAR SPONDYLOSIS. PLAINTIFF'S LAWYER ATTRIBUTED THE EVENTS TO THE PATIENT'S TREATING SURGEONS AND OTHER HEALTHCARE PROVIDERS. UNSPECIFIED MYELOTEC PRODUCT(S) WERE ALLEGEDLY MODIFIED/ALTERED BY THOSE PERSONS AND UTILIZED IN PATIENT'S PROCEDURE IN AN OFF-LABEL MANNER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other