MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-30 for COMPEX 2540660-17 manufactured by Djo, Llc.
[109530453]
Complaint received that alleges " after using the compex wireless, they were experiencing prolonged muscle tension on his arms and there were veins bulging and one of his colleagues also tried the unit and ended up with the same issue and had some veins pop up. They had to physician take a look at it and concluded that there is thickening of the blood on the affected area of the arms and they had to take a medicine to reduce the thickening and relax the muscles. There was also a slight headache that was felt after using the device".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012446970-2018-00003 |
| MDR Report Key | 7553078 |
| Report Source | CONSUMER |
| Date Received | 2018-05-30 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-05-21 |
| Date Added to Maude | 2018-05-30 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM FISHER |
| Manufacturer Street | 1460 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer G1 | DJO, LLC |
| Manufacturer Street | 3151 SCOTT STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 920819663 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPEX |
| Generic Name | COMPEX WIRELESS USA 2.0 TENS COMPLETE SET |
| Product Code | NGX |
| Date Received | 2018-05-30 |
| Model Number | 2540660-17 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1460 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-30 |