MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for FILSHIE CLIP manufactured by Femcare Ltd.
[178348687]
On (b)(6) 2018 until (b)(6) 2018 i had multiple tests, exams and exploratory surgery to find only one filshie clip. I then had to have more tests, exams and a second exploratory surgery to find the second filshie clip in (b)(6) 2019. It resulted in losing my right fallopian tube and ovary. I had a slew of tests to try and find what was causing all my pain and urinary symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092831 |
| MDR Report Key | 9681806 |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-04 |
| Date Added to Maude | 2020-02-07 |
| 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 | 2020-02-06 |
| 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; 3. Deathisabilit | 2020-02-06 |