MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-02 for * manufactured by Avalon.
[19257042]
In 2004, i had a tubal ligation performed. After surgery, i was in intense pain. The pain continued several years. My ob/gyn wasn't finding the cause. So i found an out of town doctor. This was 2006. The pain continued, so she decided to do laparoscopy surgery in 2007. She discovered that my tubes were just laying there with a bunch of scar tissue. Then she found the first missing filshie clip poking my right ovary. The second one was found pushed up against my uterus and cervix. The same two spots i had been complaining about. She took pictures of them. After i recovered, i went to the other hospital where it was performed to find out what kind of clips were used and they were avalon filshie clips. Now my tubes are just laying there. But at least the pain is gone. Dates of use: 2004 - 2007. Diagnosis or reason for use: tubal ligation.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5003326 |
MDR Report Key | 890983 |
Date Received | 2007-08-02 |
Date of Report | 2007-08-02 |
Date of Event | 2007-04-25 |
Date Added to Maude | 2007-08-13 |
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 | 0 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | * |
Generic Name | FILSHIE CLIPS |
Product Code | HGB |
Date Received | 2007-08-02 |
Model Number | * |
Catalog Number | * |
Lot Number | * |
ID Number | * |
Operator | OTHER |
Device Availability | N |
Implant Flag | Y |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 868974 |
Manufacturer | AVALON |
Manufacturer Address | * * * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other; 2. Deathisabilit | 2007-08-02 |