MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-12 for VECTRA GENISYS 2CH COMBO PKG 2761 manufactured by Djo, Llc.
[3272701]
Patient was burned and treatment was interrupted when using e-stim on interferential. Patient suffered 2nd degree burn under electrodes and was treated by wound care specialist using a cold compress and ice the first day and silvadene burn cream thereafter. Device ifu states burn as a potential adverse effect with use of electrodes. Device ifu includes warning that device should only be used with the electrodes recommended for use by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2013-00003 |
| MDR Report Key | 3062920 |
| Report Source | 06 |
| Date Received | 2013-04-12 |
| Date of Report | 2013-04-12 |
| Date of Event | 2013-03-08 |
| Date Mfgr Received | 2013-03-14 |
| Date Added to Maude | 2013-04-18 |
| 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 STREET |
| 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 B.C. 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 2CH COMBO PKG |
| Generic Name | ELECTROTHERAPY - CLINIC |
| Product Code | IMG |
| Date Received | 2013-04-12 |
| Model Number | 2761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-04-12 |