MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-23 for ENDOMED 433, RISK CLASS 2G 1433.902 manufactured by Djo Global.
[32181739]
Reporter was treated at the physical therapist's office by use of interferential current at his lower back. He experienced tingling at his lower leg and calf. Muscle spasms at his lower back. This discomfort keeps him awake. He suspects nerve damage resulting to neuropathy.
Patient Sequence No: 0, Text Type: D, B5
[36502594]
Add'l info received from reporter on 01/12/2016. Tingling sensation in calves. I could not sleep for many nights following use of device due to muscle spasms (twitching) of calves and lower back. Also happening various times during the day. I experienced weakness and lack of coordination. Sometimes feeling i was going to drop and needed support. Later i had muscle cramping problems as well. I advised (b)(6) before hand. I did not want any electro stim. He did not heed warning. Told him i had bad results in past. Ten units. Physical therapy: (b)(6) 2015, (b)(6) 2015. (b)(6).
Patient Sequence No: 0, Text Type: D, B5
[34784795]
Add'l info received from mfr on 12/29/2015: we at djo, llc have received and reviewed mw5058129: our review team was able to contact the pt, and clinic with the pt permission for add'l details. Per the pt responding to our request, the unit involved with this event was not a djo, llc device. The data given for the device is as follows: mfr: henley international; brand name: endomed 433, risk class 2g; model # 1433. 902; serial # (b)(4),
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058129 |
| MDR Report Key | 5250177 |
| Date Received | 2015-11-23 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-09-15 |
| Date Added to Maude | 2015-11-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | ENDOMED 433, RISK CLASS 2G |
| Generic Name | 'PHOTOPHERESIS' QUADPOLAR INTERFERENTIAL CONTINUOUS 9-100HZ SCAN |
| Product Code | LIH |
| Date Received | 2015-11-23 |
| Model Number | 1433.902 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DJO GLOBAL |
| Manufacturer Address | 1430 DECISION ST. VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Other | 2015-11-23 |