MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-23 for FILSHIE CLIP manufactured by .
[5236466]
I received this clips when i asked for a tubal back in 2011. I have had nothing but problems and pain ever since. I changed physicians since then because the physician who put them on did so, even when i specifically asked for them to, but cut and tied. My physician i have now, has never heard of these and had to resource to find out about them. They came back with horrible news. She said they were not good. The main problem is they are falling off and becoming dislodged elsewhere. I have been suffering in pain for the last 3 years and have had test after test looking for what the problem is and this is the only thing left. This product should be recalled and investigate before it becomes a huge problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039830 |
| MDR Report Key | 4375294 |
| Date Received | 2014-12-23 |
| Date of Report | 2014-12-23 |
| Date of Event | 2011-02-20 |
| Date Added to Maude | 2015-01-02 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILSHIE CLIP |
| Generic Name | NONE |
| Product Code | KNH |
| Date Received | 2014-12-23 |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Brand Name | FILSHIE CLIP |
| Generic Name | NONE |
| Product Code | HGB |
| Date Received | 2014-12-23 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-23 |