MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-19 for FILSHIE CLIP AVM - 851 manufactured by Cooper Surgical, Inc..
[1548265]
At the time of surgery for hysterectomy, a filshie clip was found in omentum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016005 |
| MDR Report Key | 1696440 |
| Date Received | 2010-05-19 |
| Date of Report | 2010-05-06 |
| Date of Event | 2010-05-05 |
| Date Added to Maude | 2010-05-26 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILSHIE CLIP |
| Generic Name | FALLOPIAN TUBE OCCLUDER |
| Product Code | HGB |
| Date Received | 2010-05-19 |
| Catalog Number | AVM - 851 |
| Lot Number | 19064 |
| Device Expiration Date | 2010-05-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DR. TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-19 |