MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-25 for FILSHIE CLIP manufactured by Cooper Surgical.
[39423075]
I had the filshie clips put in (b)(6) 2010 at the age of (b)(6). Since then, i've had sever cramping, migraines, irregular periods, fatigue, extreme weight gain. I have had to quit my job due to sever pain. I can also feel tearing sensations around the area of the clips, and popping feelings. I'm in so much agony i'd rather be dead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060597 |
| MDR Report Key | 5469996 |
| Date Received | 2016-02-25 |
| Date of Report | 2016-02-25 |
| Date of Event | 2010-08-01 |
| Date Added to Maude | 2016-03-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FILSHIE CLIP |
| Generic Name | FILSHIE CLIP |
| Product Code | KNH |
| Date Received | 2016-02-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Brand Name | FILSHIE CLIP |
| Generic Name | FILSHIE CLIP |
| Product Code | HGB |
| Date Received | 2016-02-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2016-02-25 |