MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-09 for FILSHIE CLIPS manufactured by Coopersurgical Inc..
[4579434]
On (b)(6) 2013 i had flishie clips placed on my left and right fallopian tubes. During the surgery, the doctor, (b)(6), accidentally cut into my uterus causing quite a bit of bleeding. The pain, also referred to as post tubal ligation syndrome, started immediately. Months went by with the pain getting worse and my quality of life went down hill. A year after the tubal ligation, i'm working towards getting my tubal reversed so i do not have to live in agony anymore. I do not recommend filshie clips to anyone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037232 |
| MDR Report Key | 3932770 |
| Date Received | 2014-07-09 |
| Date of Report | 2014-07-09 |
| Date of Event | 2013-06-28 |
| Date Added to Maude | 2014-07-15 |
| 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 | 2014-07-09 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-07-09 |