MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-10-29 for EVIDENT UNKNOWN - EMPRINT GEN manufactured by Covidien Lp - Superdimension Inc.
[165565238]
Title microwave ablation of liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions source med oncol, 2017 (1-11) date of publication: 20 february 2017. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[165565239]
According to the literature study performed from october 2014, while investigating the effects produced by a new-generation microwave ablation (mwa), out of 60 patients, 1 experienced pneumothorax during probe positioning that was resolved by immediate pleural drainage and another was complicated with liver abscess with pleural fistula and right basal pneumonia a few weeks after treatment that required percutaneous drainage with good clinical outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2019-00078 |
| MDR Report Key | 9253990 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-10-29 |
| Date of Report | 2019-10-29 |
| Date of Event | 2017-02-12 |
| Date Mfgr Received | 2019-10-15 |
| Date Added to Maude | 2019-10-29 |
| 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 | EVIDENT |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2019-10-29 |
| Model Number | UNKNOWN - EMPRINT GEN |
| Catalog Number | UNKNOWN - EMPRINT GEN |
| 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. Required No Informationntervention | 2019-10-29 |