MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-13 for VECTRA GENYSIS COMBO 2789 manufactured by Djo Llc.
[2690576]
On (b)(6) 2012, received a complaint that a pt was burned while using the product. On (b)(6) 2012, received additional info from the user facility indicating that the pt received 3rd degree burns as a result of using the product and they needed to refer the pt to the emergency department at the hospital for treatment.
Patient Sequence No: 1, Text Type: D, B5
[9858324]
The returned device was evaluated by djo and found to have met specifications and did not malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2012-00022 |
| MDR Report Key | 2542612 |
| Report Source | 06 |
| Date Received | 2012-04-13 |
| Date of Report | 2012-04-13 |
| Date of Event | 2012-02-22 |
| Date Mfgr Received | 2012-03-16 |
| Date Added to Maude | 2012-04-23 |
| 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 | 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 | 20230 SUBMETROPOLI EL FLORIDO CARRETERA LIBRE TIJUANA TECATE |
| 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 GENYSIS COMBO |
| Generic Name | ELECTROTHERAPY |
| Product Code | ILY |
| Date Received | 2012-04-13 |
| Model Number | 2789 |
| Lot Number | T2078 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO LLC |
| Manufacturer Address | 1430 DECISION ST VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-13 |