MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-10-30 for SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (19CM) H7877001060020 manufactured by Angiodynamics.
| Report Number | 1317056-2019-00133 |
| MDR Report Key | 9254611 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-30 |
| Date of Event | 2019-09-28 |
| Date Mfgr Received | 2019-09-30 |
| Date Added to Maude | 2019-10-30 |
| 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 | LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (19CM) |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2019-10-30 |
| Catalog Number | H7877001060020 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-30 |