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 TUBAL LIGATION manufactured by Femcare Ltd..
[176038065]
I had my tubes the (filshie clamps) in 2011, after that i started to have heavy bleeding, bad menstrual period, blood clots, ovarian cysts so on; (b)(6) 2019 i had a hysterectomy fallopian tubes removed and uterus not my ovaries, but (b)(6) 2020 a month later, i went to the bathroom and a clamp came out, weird. I just had a hysterectomy and my fallopian tubes were removed. I went back to my dr and he said to me he did see it in my stomach but left it because it was a complicated surgery nd he did not want to mess with me anymore also because i was bleeding a lot. Please help me out. I don't know what to do, i have the filshie clamp with me, i don't know if it was. Medical malpractice but i have heard many stories of other woman having the same issue with the clamps after tubal ligation. Thanks. Fda safety report id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092363 |
| MDR Report Key | 9610817 |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-10 |
| 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 TUBAL LIGATION |
| Generic Name | LAPAROSCOPIC, CONTRACEPTIVE TUBAL OCCLUSION |
| Product Code | KNH |
| Date Received | 2020-01-17 |
| Operator | HEALTH PROFESSIONAL |
| 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. Other | 2020-01-17 |