MAUDE Adverse Event Report: IMPETO MEDICAL SUDO SCAN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Vertigo (2134); Chills (2191); Dizziness (2194)

Event Date 09/18/2017

Event Type  Injury  

Event Description

Primary doctor stated that i needed to submit to a test involving nerves required by medicare because of falls (approx.10 falls in past 10 year).I was led to room where machine was located.Tech keyed in some information and told me to remove my shoes.I then stood on two stainless steel looking plates with my bare feet and placed both bare palms on the other two plates.I stood there for 3 minutes and tech told me to get off machine.I put shoes back on and i and my wife checked out and we went straight home.About 4-5 hours later i started "feeling" strange effects on my body, especially my spine from literally top of my head to down to my knees.I felt dizzy, intermittent chills and extreme sensitivity on skin down my back ending at the knee area.I had pain in the back of my neck just below the base of my skull.I had pain in my forehead especially on the right side ending at eyebrow.Pain was not as bad at center of forehead or left side of forehead.I had feeling of disorientation.I had a feeling of mild vertigo.This all started on (b)(6) 2017 and symptoms are still with me, though not as intense, to this day (b)(6) 2017.

Event Description

Add'l info received on (b)(6) 2018 from reporter for report mw5073310: reporter wanted to add that he had undergone an mri and was told that he had no abnormalities.He adds that the pain that was in his neck and head have now subsidedm, but now has new pain in his chest region and radiates to his back, hips, thighs and down to his knees.This pain is only on his skin (which is extremely sensitive to touch after his sudo scan treatment).This pain can even be caused by contact with clothing.He goes on to say that his vertigo, disorientation and dizziness have now subsided.

• Brand Name: SUDO SCAN
• Type of Device: SUDO SCAN
• Manufacturer (Section D): IMPETO MEDICAL
• MDR Report Key: 7027602
• MDR Text Key: 97412280
• Report Number: MW5073310
• Device Sequence Number: 1
• Product Code: GZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 84