MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-09-30 for INT LEGEND COMBO 4C 7550 manufactured by Dj Orthopedics De Mexico, S.a. De C.v..
[17408264]
Reported that during treatment with estim operation on ch 3 and 4 on ifc, unit shocked a patient while in use. The patient reported extreme pain. It is reported that there was injury under one or more electrodes and another user stated that she smelled something burning around the unit at this time, however there is no report of burn to the patient. Treating clinician reports that there was no medical intervention or delay in treatment. Device evaluation reports that there was no output for channel 3. It is unclear if the channel 3 fault is the cause of the reported injury. Djo considers any incident with extreme pain as a reportable event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00121 |
| MDR Report Key | 2275973 |
| Report Source | 06 |
| Date Received | 2011-09-30 |
| Date of Report | 2011-09-29 |
| Date of Event | 2011-01-31 |
| Date Added to Maude | 2011-10-06 |
| 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 | 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 | INT LEGEND COMBO 4C |
| Generic Name | ELECTROTHERAPY |
| Product Code | IMI |
| Date Received | 2011-09-30 |
| Model Number | 7550 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Address | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO TIJUANA 22244 MX 22244 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-30 |