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

Device Problem Nonstandard Device (1420)

Patient Problems Cyst(s) (1800); Pain (1994); Ambulation Difficulties (2544); Fibrosis (3167); Pregnancy (3193)

Event Date 12/21/2007

Event Type  Injury  

Event Description

On (b)(6) 2007 i had a failure bilateral tubal ligation, with filshie clips, done at (b)(6) hospital in (b)(6).The doctor had about 4-6 or more students and/or staff with him during my procedure.I felt everything they done to me after the medicine to numb my body, that was injected into me did not work good until after the procedure was over.It felt like they were taking scissors pulling my insides out.I was in so much pain after the surgery.I could not help myself.I felt less than a woman.I became pregnant 5 - 6 months later.I went back to (b)(6) hospital in (b)(6) after i took a home test.It took them 4 hours to get me seen after i told them that i was pregnant with my tubes tied.After they figured out the baby made it to the uterus they asked me if i wanted an abortion.Since the procedure i've had 2 son's.But i have the most pain where my ovaries and tubes are.Especially when i have my cycle.I can barely walk.I have so much pain in my legs.I have 2 fibroids and a cyst on my ovaries since this procedure.My pelvic bone broke when i was pregnant after having the 1st baby with my tubes tied.I am going to a (b)(6) hospital to get test done to see what other major damage has been caused.The 1st son after the procedure was done was born in (b)(6), the 2nd son was born in (b)(6).I wrote (b)(6) hospital about the situation they said they couldn't help me.At 1 of my appts a nurse told me the recall on the filshie clips and they were experimenting back then.I believe something need to be done about this horrible, painful product.The company should be sued or shut down.Having 2 more kids than i was expecting has caused so much of a hardship on me.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: 10108842
• MDR Text Key: 193930881
• Report Number: MW5094781
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Weight: 87