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 2019-11-24 for FLEX-CATCH 4 WIRE NITINOL BASKET NT4F19115 manufactured by Gyrus Acmi, Inc.
| Report Number | 3003790304-2019-00004 |
| MDR Report Key | 9367085 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-24 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-03-27 |
| Date Added to Maude | 2019-11-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEX-CATCH 4 WIRE NITINOL BASKET |
| Generic Name | EXTRACTOR, STONE REMOVAL |
| Product Code | FGO |
| Date Received | 2019-11-24 |
| Returned To Mfg | 2020-01-30 |
| Model Number | NT4F19115 |
| Lot Number | 91807222 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-24 |