MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for EBPRO manufactured by Erchonia Corporation.
[183737459]
This is regarding the ebpro by erchonia corp. I am a user of the device. I can smell chlorine gas during and immediately after using the device in a closed room of the size of approx 8x8x8 feet. Pure table salt was added to the water bath, per instructions in the manual. Tap water was used, but the water wasn't heavily chlorinated. I experienced dizziness during and after treatment. The symptoms subsided when i walked out to an open space. I suspect the device produces chlorine gas, with the chloride element coming from the table salt nacl. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093715 |
| MDR Report Key | 9828877 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-12 |
| Date Added to Maude | 2020-03-13 |
| 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 | EBPRO |
| Generic Name | DEVICE, IONTOPHORESIS, OTHER USES |
| Product Code | EGJ |
| Date Received | 2020-03-12 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERCHONIA CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |