MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-01 for FILSHIE CLIP manufactured by .
[39742901]
I had my tubal ligation in 2012 using filshie clips. Early in 2015, i started experiencing severe lower abdominal pain. After many tests and not knowing what was wrong, my doctor did a diagnostic laparoscopic surgery and found that both of my clips had migrated off of my tubes. The one on my right had moved into my lower abdomen, causing the pain. The left one was not able to be removed and is still lodged behind my liver. I suffer ptsd and severe anxiety related to my health now that i did not have before.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060752 |
| MDR Report Key | 5479588 |
| Date Received | 2016-03-01 |
| Date of Report | 2016-03-01 |
| Date Added to Maude | 2016-03-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 0 |
| Brand Name | FILSHIE CLIP |
| Generic Name | FILSHIE CLIP |
| Product Code | KNH |
| Date Received | 2016-03-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Brand Name | FILSHIE CLIP |
| Generic Name | FILSHIE CLIP |
| Product Code | HGB |
| Date Received | 2016-03-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2016-03-01 |