MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-28 for INTELECT TERANSPORT 2C STIM 2783 manufactured by Djo Global.
[2043440]
Customer stated four patients burned using ifu stim. Requested customer return unit, leadwires, and electrodes for testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00091 |
| MDR Report Key | 2190881 |
| Report Source | 05 |
| Date Received | 2011-07-28 |
| Date of Report | 2011-07-28 |
| Date of Event | 2011-07-01 |
| Date Mfgr Received | 2011-07-14 |
| Date Added to Maude | 2011-08-08 |
| 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 | 0 |
| Health Professional | 3 |
| 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 |
| 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 | INTELECT TERANSPORT 2C STIM |
| Generic Name | ELECTROTHERAPY |
| Product Code | IMG |
| Date Received | 2011-07-28 |
| Returned To Mfg | 2011-07-14 |
| Catalog Number | 2783 |
| 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 GLOBAL |
| Manufacturer Address | VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-28 |