inforMED
InjuryILY

LIFE VESSEL

Received Nov 20, 2008 · Event occurred Nov 3, 2008

Report MW5009076 · MDR key 1245809

Device

Generic name

Life Vessel

Product problems

  • Unknown (for use when the device problem is not known)

Patient

37 YR

  • Headache
  • Visual Disturbances
  • Dizziness

Narrative

Description of Event or Problem

I WAS SUBJECTED TO TREATMENTS IN A DEVICE KNOWN AS A "LIFE VESSEL". THE TREATMENTS WERE ADMINISTERED IN THE OFFICE OF A DR. THESE TREATMENTS WERE UNDER THE PREMISE OF RELAXATION AND CIRCULATION IMPROVEMENT. THE LIFE VESSEL IS SUPPOSEDLY FDA APPROVED. I BELIEVE THE APPROVAL AND DATED 2007. I RECEIVED 4 TREATMENTS, AND STARTING THE DAY AFTER THE FOURTH TREATMENT IN 2008, I STARTED EXPERIENCING SEVERE HEADACHES, DIZZINESS AND DISTORTED VISION/FOCUS. THE DOCTOR IN QUESTION HAS BEEN STEADFAST IN DENYING THE MACHINE HAD ANYTHING TO DO WITH THE SITUATION. SHE HAS REFUSED TO DIVULGE ANY INFORMATION REGARDING THE MACHINE IN REGARDS TO POSSIBLE EFFECTS AND HOW THE MACHINE WORKS. THE SYMPTOMS HAVE BEEN ON-GOING NOW FOR 17 DAYS. I HAVE BEEN PLEADING WITH THE DOCTOR TO RELEASE INFORMATION ON THE MACHINE MAY HAVE EFFECT ON MY AUTONOMIC NERVOUS SYSTEM, BUT SHE STILL DENIES THE MACHINES NEGATIVE EFFECT. BEFORE THESE TREATMENTS, I HAVE NEVER SUFFERED ANY OF THESE SYMPTOMS, EVER. MY MAIN FOCUS OF THIS COMPLAINT IS TO FORCE HER TO DIVULGE THE WORKINGS OF THE MACHINE AND HOW IT CAN EFFECT THE AUTONOMIC NERVOUS SYSTEM. DATES OF USE: 2008. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: NO. DIAGNOSIS OR REASON FOR USE: CIRCULATION IMPROVEMENT.