MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-22 for NEUWAVE LK PROBE 15CM 17GA LK15 manufactured by Neuwave Medical, Inc..
| Report Number | 3008769756-2019-00051 |
| MDR Report Key | 9364257 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-04 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-11-04 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 3529 ANDERSON ST |
| Manufacturer City | MADISON 53704 |
| Manufacturer Country | US |
| Manufacturer Postal | 53704 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | NEUWAVE MEDICAL, INC. |
| Manufacturer Street | 3529 ANDERSON ST |
| Manufacturer City | MADISON 53704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUWAVE LK PROBE 15CM 17GA |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2019-11-22 |
| Catalog Number | LK15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUWAVE MEDICAL, INC. |
| Manufacturer Address | 3529 ANDERSON ST MADISON 53704 US 53704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-11-22 |