VITALITY SCANNER 2006

Additional Manufacturer Narrative

PATIENT INFORMATION WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED. IT WAS INITIALLY REPORTED BY A DEALER REPRESENTATIVE THAT NO INJURY WAS ASSOCIATED WITH THIS INCIDENT. DURING A FOLLOW UP PHONE CALL ON (B)(4) 2013 WITH THE DEALER REPRESENTATIVE, IT WAS REPORTED THAT THE SHOCK THE DOCTOR HAD RECEIVED WAS "A SURPRISE", BUT WAS NOT PAINFUL AT ALL. UPON FURTHER EVALUATION OF THE COMPLAINT, THE DEALER REPRESENTATIVE WAS CONTACTED A SECOND TIME ON (B)(4) 2013 AND THE CUSTOMER'S CONTACT INFORMATION WAS REQUESTED. DURING A FOLLOW UP PHONE CALL WITH THE DOCTOR'S OFFICE, IT WAS REVEALED THAT THE DOCTOR HAD REPORTED THE SHOCK SHE RECEIVED AS "EXTREMELY PAINFUL" WITH PAIN THAT HAD LASTED FOR A FEW DAYS FOLLOWING. NO MEDICAL ATTENTION OR PRESCRIPTION MEDICATION WAS REQUIRED; THE SYMPTOMS SUBSIDED ON THEIR OWN. TO DATE, THE DOCTOR HAS FULLY RECOVERED AND IS DOING FINE. THE DEVICE WAS RETURNED AND AN EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN.

Description of Event or Problem

A DOCTOR ALLEGED THAT SHE HAD RECEIVED A HIGH SHOCK WHILE TESTING THE VITALITY SCANNER 2006 UNIT ON HERSELF.