MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-31 for FILSHIE CLIP manufactured by Femcare Ltd..
[173502188]
I had a schedule c-section followed by tubal ligation, i specified no clips. To my horror a few years later an x-ray showed surgical clips and my most current ct scan shows the clips have migrated and is the only possible cause to my severe abdominal pain. I found out they used filshie clips and thousands of other women have dealt with being unaware they had them until migration and complications along with post tubal ligation syndrome. Filshie clips need to have a warning and drs need to really sit down with their pts and explain everything to them. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091966 |
| MDR Report Key | 9539118 |
| Date Received | 2019-12-31 |
| Date of Report | 2019-12-27 |
| Date of Event | 2011-07-25 |
| Date Added to Maude | 2020-01-02 |
| 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 | 3 |
| Brand Name | FILSHIE CLIP |
| Generic Name | LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE |
| Product Code | KNH |
| Date Received | 2019-12-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FEMCARE LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-12-31 |