MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-10-30 for UNKNOWN EMPRINT GENERATOR manufactured by Covidien Lp - Superdimension Inc.
[178623961]
(b)(4). Title treatment of lung tumours with high-energy microwave ablation: a single-centre experience source med oncol, volume 34, 2017(1-7) article number: 5 date of publication online: 30 november 2016. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178623962]
According to the literature study performed, in a study reporting the safety, technical success, effectiveness, local progression-free survival (lpfs) and overall survival of percutaneous microwave ablation (mwa) to treat lung tumors unsuitable for surgery. Nineteen patients with thirty-one tumors (mean diameter 2. 4 cm) underwent percutaneous mwa in 28 sessions that was carried out using a 2450 mhz generator with an ablation median of 7 minutes, out of 28, 1 patient developed purulent hydro-pneumothorax that required a pleural drainage, antibiotic therapy that delayed the patient discharge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2019-00079 |
| MDR Report Key | 9258205 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-30 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2019-10-15 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN EMPRINT GENERATOR |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2019-10-30 |
| Model Number | UNKNOWN EMPRINT GENERATOR |
| Catalog Number | UNKNOWN EMPRINT GENERATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Address | 161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-10-30 |