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MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5003326
MDR Report Key890983
Date Received2007-08-02
Date of Report2007-08-02
Date of Event2007-04-25
Date Added to Maude2007-08-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameFILSHIE CLIPS
Product CodeHGB
Date Received2007-08-02
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device AvailabilityN
Implant FlagY
Date RemovedB
Device Sequence No1
Device Event Key868974
ManufacturerAVALON
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2007-08-02

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