MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for FILSHIE CLIPS manufactured by Femcare Ltd..
[176035571]
I had filshie clips put in a week after (b)(6) 2015 and had one of the clips shred my right fallopian tube and attach itself to my bowel wall; i was told if i would have moved just right i would have ripped a hole in my wall and gone septic. I had my ob/gyn removed the clips. Later in 2017 i had a hysterectomy due to continuous pain from being torn to shreds. Fda safety report id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092362 |
| MDR Report Key | 9610794 |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-15 |
| Date of Event | 2016-09-20 |
| Date Added to Maude | 2020-01-21 |
| 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 | 2020-01-17 |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-17 |