MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-07-24 for CHATTANOOGA INTELECT LEGEND manufactured by Djo, Llc.
[3890531]
Pt was given a treatment using electronic stimulation and the pt reported receiving a shock. The pt is now alleging injuries as a result of the shock. Djo, llc became aware of the reported event on (b)(4) 2013. The device has not been returned to djo, llc for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[10933591]
Investigation was initiated by regulatory affairs on our aware date of (b)(4) 2013. Follow up reports will be provided as more information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2013-00012 |
| MDR Report Key | 3281199 |
| Report Source | 99 |
| Date Received | 2013-07-24 |
| Date of Event | 2011-05-16 |
| Date Added to Maude | 2013-10-21 |
| 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 G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRA 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 | CHATTANOOGA INTELECT LEGEND |
| Generic Name | INTELECT LEGEND |
| Product Code | IMG |
| Date Received | 2013-07-24 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-24 |