MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for FILSHIE CLIPS manufactured by Cooper Surgical/femcare Ltd..
[174666016]
On (b)(6) 2019 i went to the er for abdominal pain and discovered via ct scan that the filshie clip on from the left tube had migrated and is lodged in my spleen. At this time i am unsure if my general surgeon is going to risk the life threatening complications to remove it. Two gynecologists have told me that filshie clips commonly migrate, which was never mentioned prior to my tubal ligation. One of those doctors refused to report migration to the fda as an adverse event so i think your date is severely flawed. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092136 |
| MDR Report Key | 9570364 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-07 |
| Date Added to Maude | 2020-01-09 |
| 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 CLIPS |
| Generic Name | LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE |
| Product Code | KNH |
| Date Received | 2020-01-08 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL/FEMCARE LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-08 |