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 2019-09-19 for WEB LOW PROFILE SL-USA W4-6-5FOR US FGA25060-050 manufactured by Sequent Medical, Inc.
| Report Number | 2032493-2019-00228 |
| MDR Report Key | 9091608 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-19 |
| Date of Report | 2019-08-20 |
| Date of Event | 2019-08-20 |
| Date Mfgr Received | 2019-08-20 |
| Device Manufacturer Date | 2019-03-29 |
| Date Added to Maude | 2019-09-19 |
| 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 | MR. MORGAN HOLODY |
| Manufacturer Street | 35 ENTERPRISE DRIVE |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEB LOW PROFILE SL-USA W4-6-5FOR US |
| Generic Name | WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM, PRODUCT |
| Product Code | OPR |
| Date Received | 2019-09-19 |
| Model Number | FGA25060-050 |
| Catalog Number | FGA25060-050 |
| Lot Number | 19032908 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEQUENT MEDICAL, INC |
| Manufacturer Address | 11 A COLUMBIA ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-09-19 |