MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-10 for CHATTANOOGA LEGEND COMBO 2C UNK manufactured by Chattanooga.
[39890458]
Patient was prepped for ifc (interferential current) electrical stimulation treatment using a electrotherapy unit in physical therapy. When treatment was started the patient stated feeling a higher intensity than accustomed to, that was uncomfortable. Unit was turned off and disconnected from patient and turned over to biomedical equipment maintenance for inspection. Patient had no injury or reaction effect, and treatment was continued with other electrotherapy unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5483229 |
| MDR Report Key | 5483229 |
| Date Received | 2004-12-10 |
| Date of Report | 2004-12-13 |
| Date of Event | 2004-11-10 |
| Date Facility Aware | 2004-12-09 |
| Report Date | 2004-12-13 |
| Date Reported to FDA | 2004-12-14 |
| Date Reported to Mfgr | 2004-12-14 |
| Date Added to Maude | 2016-03-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHATTANOOGA |
| Generic Name | ELECTROTHERAPY |
| Product Code | LIH |
| Date Received | 2004-12-10 |
| Model Number | LEGEND COMBO 2C |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA |
| Manufacturer Address | 4717 ADAMS RD. PO BOX 489 HIXSON TN 37343 US 37343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-12-10 |