MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-21 for LEGEND XT 4CH COMBO PKG 2788 manufactured by Djo, Llc.
[2596570]
Patient suffered a burn on the forearm from an electrode during electrotherapy treatment. The patient sought and received additional treatment from a medical facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2012-00017 |
| MDR Report Key | 2503073 |
| Report Source | 05 |
| Date Received | 2012-03-21 |
| Date of Report | 2012-03-21 |
| Date Added to Maude | 2012-03-27 |
| 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 | 20230 SUBMETROPOLI EL FLORIDO CARRETERA LIBRE TIJUANA TECATE |
| 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 | LEGEND XT 4CH COMBO PKG |
| Generic Name | ELECTROTHERAPY - CLINIC |
| Product Code | GZI |
| Date Received | 2012-03-21 |
| Model Number | 2788 |
| 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 | VISTA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-21 |