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

Model Number AVM851

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Emotional Changes (1831); Fever (1858); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Abdominal Distention (2601)

Event Type  Injury  

Event Description

I has a tubal ligation done using filshie clips made by cooper surgical back in 2014.Since then i have unexplained fevers, 9 utis in one year, bloating, abdominal pain, a rash for the last year and has only become worse, painful sex that becomes crippling more often than not, mood changes.I have seen many ob gyn's, gastro, urology, my primary, emergency rooms.I've had two endoscopies, a colonoscopy, cat scans, lab work, x rays.One xray confirming that the clip on the left fallopian tube has migrated to the right side.I was diagnosed with pmdd for the mood changes.I become very angry, sad, on edge.I am a shell of myself before my surgery.I was also diagnosed with ins for the bloating, pain and 2+ years of diarrhea only.The current rash covering my vaginal area was biopsied and initially was diagnosed with localized chronic dermatitis.That was later changed when i asked my doctor if my clips could be causing this.I had allergy testing done and determined i am highly allergic to nickel.Filshie clips contain trace nickel in the outer silicone portion of the clip.My doctor kept insisting the clips were plastic until my allergist requested more information and finally told me that there was in fact nickel in the filshie clips.I have almost exact symptoms as patients with adverse effects from the essure device, which also contains nickel.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL, INC.
• MDR Report Key: 8912487
• MDR Text Key: 155182144
• Report Number: MW5089192
• 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: 08/16/2019

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: Lay User/Patient
• Device Model Number: AVM851
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 30 YR
• Patient Weight: 61