MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for SUDO SCAN manufactured by Impeto Medical.
[97412280]
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.
Patient Sequence No: 1, Text Type: D, B5
[101647401]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073310 |
| MDR Report Key | 7027602 |
| Date Received | 2017-11-13 |
| Date of Report | 2018-01-02 |
| Date of Event | 2017-09-18 |
| Date Added to Maude | 2017-11-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUDO SCAN |
| Generic Name | SUDO SCAN |
| Product Code | GZO |
| Date Received | 2017-11-13 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPETO MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-11-13 |