MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-04 for FILSHIE CLIP * manufactured by Cooper Surgical.
[18577970]
During a laparoscopic procedure, a loose filshie clip was found lying inside the operative site. The patient had not had previous surgery at this facility. Unknown date and facility for previous procedure. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1311224 |
| MDR Report Key | 1311224 |
| Date Received | 2009-02-04 |
| Date of Report | 2009-02-04 |
| Date of Event | 2009-01-23 |
| Report Date | 2009-02-04 |
| Date Reported to FDA | 2009-02-04 |
| Date Added to Maude | 2009-02-13 |
| 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 CLIP |
| Generic Name | CLIP, TUBAL OCCLUSION |
| Product Code | HGB |
| Date Received | 2009-02-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-04 |