MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-08 for DUALSTIM NS-2CA manufactured by Life-tech, Inc..
[92952]
A 35 yr old female undergoing gastric 2. 5 cm superficial burns on left wrist. Burn sites were beneath surface electrodes connected to peripheral nerve stimulator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 147995 |
| MDR Report Key | 147995 |
| Date Received | 1998-01-08 |
| Date of Report | 1997-09-11 |
| Date of Event | 1997-07-03 |
| Date Facility Aware | 1997-07-03 |
| Report Date | 1997-09-11 |
| Date Reported to Mfgr | 1997-10-03 |
| Date Added to Maude | 1998-02-11 |
| 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 | DUALSTIM |
| Generic Name | PERIPHERAL NERVE STIMULATOR |
| Product Code | KOI |
| Date Received | 1998-01-08 |
| Model Number | NS-2CA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 144207 |
| Manufacturer | LIFE-TECH, INC. |
| Manufacturer Address | P.O. BOX 36221 HOUSTON TX 772366221 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-01-08 |