MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-22 for REUSABLE ELECTRODE, 10CM, NITINOL RF-NE-10 manufactured by Minta Medical Limited.
| Report Number | 3004617090-2019-00001 |
| MDR Report Key | 9365173 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2019-11-04 |
| Device Manufacturer Date | 2018-06-14 |
| Date Added to Maude | 2019-11-22 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | MINTA MEDICAL LIMITED |
| Manufacturer Street | CADDICK ROAD |
| Manufacturer City | MERSEYSIDE KNOWSLEY L34 9HP |
| Manufacturer Country | UK |
| Manufacturer Postal Code | L34 9HP |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REUSABLE ELECTRODE, 10CM, NITINOL |
| Generic Name | PROBE, RADIOFREQUENCY LESION |
| Product Code | GXI |
| Date Received | 2019-11-22 |
| Model Number | RF-NE-10 |
| Catalog Number | RF-NE-10 |
| Lot Number | M14329 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINTA MEDICAL LIMITED |
| Manufacturer Address | CADDICK ROAD MERSEYSIDE KNOWSLEY L34 9HP UK L34 9HP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-22 |