MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for TUBAL FILSHIE CLIP manufactured by Femcaer Ltd..
[174668885]
The filshie clip that was on my left ovary migrated to my stomach near my kidneys. I am in serious pain all of the time. I am in fear that if the clip doesn't get removed, that it will migrate to my colon, and cause me to die. I am also in fear that i could have inflammation in my stomach from the clip migrating. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092149 |
| MDR Report Key | 9575596 |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-08 |
| Date Added to Maude | 2020-01-10 |
| 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 | TUBAL FILSHIE CLIP |
| Generic Name | LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCUSION DEVICE |
| Product Code | KNH |
| Date Received | 2020-01-09 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FEMCAER LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2020-01-09 |