MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-01-07 for SET WIRELESS SP6.0 MULTILINGUAL US PLUG 2538660 manufactured by Djo, Llc.
[132264034]
The device was received and a follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[132264035]
It was reported that the patient started to have subtle seizures after a couple days of using the device. The patient's doctor explained to the patient that he was having epileptic seizures and advised him to stop using the device immediately. The seizures involved an involuntary slight turn on his head, blink of his eye, and then a feeling that he was about to faint. After this, he experienced headaches that could last for an hour. The device labeling states "epilepsy. If you have suspected or diagnosed epilepsy, you should follow the precautions for use recommended by your doctor. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007615436-2019-00001 |
| MDR Report Key | 8223328 |
| Report Source | FOREIGN |
| Date Received | 2019-01-07 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2019-01-17 |
| Date Added to Maude | 2019-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BECKER |
| Manufacturer Street | 3151 SCOTT STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJO TUNISIE |
| Manufacturer Street | ZONE INDUSTRIELLE POUDRIERE 1 AOUT |
| Manufacturer City | SFAX SFAX 3002 |
| Manufacturer Country | TS |
| Manufacturer Postal Code | 3002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SET WIRELESS SP6.0 MULTILINGUAL US PLUG |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | NGX |
| Date Received | 2019-01-07 |
| Returned To Mfg | 2018-12-27 |
| Model Number | 2538660 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 3151 SCOTT STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-01-07 |