MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for FILSHIE CLIPS manufactured by Femcare Ltd..
[180629899]
Pt was implanted with filshie clips in 2010. In (b)(6) of 2011, the pt said she was hospitalized in the icu for a few months due to her immune system attacking her body. Pt stated that her body was rejecting the filshie clips as a foreign object. Pt said she was hospitalized again in 2015 for a few weeks for autoimmune disease. Pt stated she now has cognitive delays, autoimmune disease, stronger periods, extreme back pain, and migraines. Pt stated before the filshie clips were implanted she had no medical problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093089 |
| MDR Report Key | 9729085 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 2010-08-01 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| Product Code | KNH |
| Date Received | 2020-02-18 |
| Device Availability | * |
| 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 | 2020-02-18 |