MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-04-03 for VECTRA GENISYS 2761 manufactured by Djo, Llc.
[2620557]
The pt was treated with the device for an orthopedic injury. Pt complained of a burning sensation during the e-stim treatment. Device was turned off, pads removed, and pads were repositioned in separate spots. The pt complained of burning sensation for a moment then reported feeling a tingling sensation in the other patches. Pt asked that the inferential current intensity be turned down. At the end of the treatment, the physical therapy assistant removed the pads and noted no problems. Pt left the office and then called the office about 45 minutes later reporting 3 areas of redness. He returned to the office and the physical therapist found 3 areas of redness and yellow/green skin breakdown. The pt was treated in the emergency department for the burns. Device was not returned for mfr. No add'l info was received regarding the complaint. The customer was contacted to gather add'l info with no response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2012-00019 |
| MDR Report Key | 2534604 |
| Report Source | 00 |
| Date Received | 2012-04-03 |
| Date of Report | 2012-04-03 |
| Date of Event | 2011-02-15 |
| Date Mfgr Received | 2012-03-05 |
| Date Added to Maude | 2012-04-16 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VECTRA GENISYS |
| Generic Name | ELECTROTHERAPY - CLINIC |
| Product Code | IMG |
| Date Received | 2012-04-03 |
| Model Number | 2761 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | VISTA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-03 |