MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-16 for CASCADE ELITE 190239-2000 manufactured by Cadwell Laboratories Inc..
[2552468]
A burn resulted from a eeg ground pad on the patient on the lower left extremity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2497872 |
| MDR Report Key | 2497872 |
| Date Received | 2012-03-16 |
| Date of Report | 2012-03-16 |
| Date of Event | 2012-01-25 |
| Report Date | 2012-03-16 |
| Date Reported to FDA | 2012-03-16 |
| Date Added to Maude | 2012-03-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASCADE ELITE |
| Generic Name | STIMULATOR, ELECTRICAL, NEUROMUSCULAR |
| Product Code | GWE |
| Date Received | 2012-03-16 |
| Returned To Mfg | 2012-02-15 |
| Model Number | CASCADE ELITE |
| Catalog Number | 190239-2000 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CADWELL LABORATORIES INC. |
| Manufacturer Address | 909 N. KELLOGG STREET KENNEWICK WA 99336 US 99336 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-16 |