MAUDE Adverse Event Report: COOPER SURGICAL INC. / FEMCARE LTD. FILSHIE CLIPS ; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 10/01/2017

Event Type  Injury  

Event Description

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).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL INC. / FEMCARE LTD.
• MDR Report Key: 9682513
• MDR Text Key: 178199772
• Report Number: MW5092846
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: KRATOM ; PROZAC ; VYVANSE ; WELLBURTIN
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 32 YR
• Patient Weight: 61