MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-13 for FILSHIE CLIPS manufactured by Cooper Surgical Trumbull Ct.
[5384934]
In (b)(6) 2008 i received filshie clips without my knowledge. I have severe stabbing pain, i break out in hives daily, severe migraines, memory loss and fatigue. They have ruined my life and thousands of other women. Was not told and was not informed of side effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040294 |
| MDR Report Key | 4438848 |
| Date Received | 2015-01-13 |
| Date of Report | 2015-01-13 |
| Date of Event | 2015-01-13 |
| Date Added to Maude | 2015-01-22 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| 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 CLIPS |
| Generic Name | FILSHIE CLIPS |
| Product Code | HGB |
| Date Received | 2015-01-13 |
| ID Number | HOWARD BEAUMONT STUART CT, SPU |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL TRUMBULL CT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2015-01-13 |