MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-13 for X BODY X BODY NEW WAVE manufactured by X-body International.
[80333134]
Electrical muscle stimulation suits have been practiced in (b)(6) at a store called (b)(6). I have had neurological pain since i had my training at (b)(6). Upon come research, i found that this bodysuit is not approved in the united states. I believe they are also training children under the age of 18.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071000 |
| MDR Report Key | 6717221 |
| Date Received | 2017-07-13 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-02-18 |
| Date Added to Maude | 2017-07-17 |
| 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 | 0 |
| Brand Name | X BODY |
| Generic Name | EMS MACHINE, STIMULATOR, MUSCLE, POWERED |
| Product Code | IPF |
| Date Received | 2017-07-13 |
| Model Number | X BODY NEW WAVE |
| Device Expiration Date | 2017-07-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | X-BODY INTERNATIONAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2017-07-13 |