MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-07 for FILSHIE * AVM-851 manufactured by Cooper Surgical, Inc.
[3063412]
Filshie clip did not deploy correctly during application.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2909186 |
| MDR Report Key | 2909186 |
| Date Received | 2013-01-07 |
| Date of Report | 2013-01-07 |
| Date of Event | 2012-12-26 |
| Report Date | 2013-01-07 |
| Date Reported to FDA | 2013-01-07 |
| Date Added to Maude | 2013-01-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILSHIE |
| Generic Name | DEVICE, OCCLUSION |
| Product Code | HGB |
| Date Received | 2013-01-07 |
| Model Number | * |
| Catalog Number | AVM-851 |
| Lot Number | 27685 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 0 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL, INC |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-07 |