MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-22 for FILSHIE CLIP manufactured by Coopersurgical.
[43868573]
I went in on (b)(6) 2014 for a tubal ligation cut and catheterization. In (b)(6) 2015, i found out that i was 6 weeks pregnant and the embryo made it all the way to my uterus. During my pregnancy i was in and out of the hospital with severe pelvic pain. So after i had the baby, a different doctor went in to remove the filshie clips and was only able to remove one. The other one is still floating by my uterus. I'm still in a great deal of pain because of this clip. I feel sick everyday, my hair is falling out, it's to the point of er visits and no answers to why i'm in so much pain. Something needs to be done about these clips. It is making women's lives miserable. Please look into these complaints, cause something is seriously wrong with these filshie clips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061904 |
| MDR Report Key | 5612169 |
| Date Received | 2016-04-22 |
| Date of Report | 2016-04-22 |
| Date of Event | 2014-12-09 |
| Date Added to Maude | 2016-04-27 |
| 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 | 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 | TUBAL OCCLUSION, CONTRACEPTION |
| Product Code | KNH |
| Date Received | 2016-04-22 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL |
| Brand Name | FILSHIE CLIP |
| Generic Name | TUBAL OCCLUSION, CONTRACEPTION |
| Product Code | HGB |
| Date Received | 2016-04-22 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2016-04-22 |