FILSHIE CLIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-07 for FILSHIE CLIPS manufactured by Cooper Surgical Inc. / Femcare Ltd..

Event Text Entries

[178199772] I am unsure of the exact date that my symptoms arose, but i had filshie clips used for my tubal ligation on (b)(6) 2015. I was not given any info about these clips, nor did i consent to having them. After this date sometime, i began to have unusual amount of back pain and utilized the service of my physician to treat and diagnose my pain. They took a series of x-rays and ct scans and i began to study them. I could see on the films that my filshie clips were migrating, and with each x-ray they were shown in a different position. For two years, i had excruciating back pain to the point that i could not even use the toilet due to the pain. My gynecologist decided to remove the clips surgically, because he and i both came to the conclusion that one of the filshie clips had embedded into my sacrum in the inside of my pelvis. The surgery happened in late 2017 i believe. When he removed the clips he also had to remove a lot of adhesions. Having to deal with the drs and surgery was terrible, and i suffered for 2 years because of these clips. Shamefully, because of the pain i was in, i made two attempts of suicide while in pain. These clips are dangerous and should not be used. I have a series of x-rays and ct scans that i can provide, as well as records of multiple dr appts. I even filed for disability. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092846
• MDR Report Key: 9682513
• Date Received: 2020-02-07
• Date of Report: 2020-02-05
• Date of Event: 2017-10-01
• Date Added to Maude: 2020-02-07
• 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: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FILSHIE CLIPS
• Generic Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Product Code: KNH
• Date Received: 2020-02-07
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOPER SURGICAL INC. / FEMCARE LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit	2020-02-07