MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-13 for NIM-ECLIPSE? ELECTRODE NRE1003 manufactured by Medtronic Xomed Inc..
[116895836]
No analysis was performed as the device has not been returned at this time. A follow up report will be submitted if the device or component is returned at a later date. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[116895837]
A healthcare professional reported via a manufacturer representative that the patient suffered a third degree burn on the right iliac crest at the location of the grounded plate. Medical history of the patient included penicillin allergy, and no smoking, alcohol, or drugs. It was noted that the device was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
[120541456]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[120541457]
Additional information received from the manufacturer representative indicated that the burn was around five square centimeters. They didn't know what was done to treat the burn or if the patient recovered without sequela. The burn was discovered after the surgery in the patient room. They didn't know if electrosurgical equipment was being used. The components of the system were put in the rubbish and the nurse wasn't sure about the serial number of the equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2018-00365 |
| MDR Report Key | 7776884 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-13 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2018-08-20 |
| Date Added to Maude | 2018-08-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DR. N. |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIM-ECLIPSE? ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2018-08-13 |
| Model Number | NRE1003 |
| Catalog Number | NRE1003 |
| Lot Number | 170731002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-13 |