MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-16 for FILSHIE CLIP manufactured by Femcare.
[901466]
Patient presented in 2008 after 1/08 eab. She had had a tubal ligation with filshie clips in 2006. In 2008, she underwent an exploratory laparoscopy and repeat tubal ligation with falope rings. During surgery, i noted that the right clip was in place but the left filshie clip was missing. Upon further investigation, the left tube was consistent with proper prior placement of the clip secondary to visualized compression injury on the tube. This is the third filshie clip malfunction since i became a licensed physician in 2000. I thought that you should be aware. Dates of use: 2006 - 2008. Diagnosis or reason for use: desired sterility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007667 |
| MDR Report Key | 1077553 |
| Date Received | 2008-07-16 |
| Date of Report | 2008-07-16 |
| Date of Event | 2008-06-26 |
| Date Added to Maude | 2008-07-29 |
| 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 |
| Health Professional | 3 |
| 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 | FILSHIE CLIP |
| Product Code | HGB |
| Date Received | 2008-07-16 |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1047865 |
| Manufacturer | FEMCARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-07-16 |