MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-20 for WEB SL 17 SINGLE LAYER W5-6-3 FG29060-030 manufactured by Sequent Medical, Inc.
| Report Number | 2032493-2019-00229 |
| MDR Report Key | 9101388 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-09-20 |
| Date of Report | 2019-08-21 |
| Date of Event | 2019-08-21 |
| Date Mfgr Received | 2019-08-21 |
| Device Manufacturer Date | 2019-05-14 |
| Date Added to Maude | 2019-09-20 |
| 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 SL 17 SINGLE LAYER W5-6-3 |
| Generic Name | WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM |
| Product Code | OPR |
| Date Received | 2019-09-20 |
| Returned To Mfg | 2019-08-27 |
| Model Number | FG29060-030 |
| Lot Number | 19051417 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-09-20 |