MAUDE Adverse Event Report: COOPER MEDICAL/FEMCARE LTD. FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problems Entrapment of Device (1212); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Emotional Changes (1831); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Pain (1994); Skin Discoloration (2074); Skin Irritation (2076); Skin Inflammation (2443); Heavier Menses (2666); Foreign Body In Patient (2687)

Event Date 06/15/2018

Event Type  Injury  

Event Description

Back in a (b)(6) 2011 i had a tubal.Unbeknownst to me they left metal filshie clips behind.I am allergic to nickel.My doctor had not been made aware of the clips containing nickel.Over the course of the following 7 years i had severe eczema on my hand and body so bad i looked like a burn victim.Along with this, i had extreme pain during menstruation and such a heavy flow i wound up getting a uterine oblation to relieve having to deal with the flow.It didn't stop the pain.Vaginal dryness so bad i'd have to use oil suppositories to help.Moodiness, over sick feeling, then in 2018, i got a hip x-ray for sharp pains in my right hip and found put i had these clips from the x-ray technician!! immediately called my doctor and went for an appointment that week.Together we called cooper medical (the manufacturer) were they confirmed that these clips contain nickel.My doctor agreed to remove them the following week.During the surgery one of the clips wee not in place and hdf to be found through explanatory surgery.I no have fallopian tubes since they took the one with the clip still attached that had a huge cyst on it.The other one is floating in my body somewhere after detaching with the clip.This cost me $6000.But 2 weeks later all the eczema was gone and i felt better.Then i started getting sharp pa ins on my left side.Went for a bunch of testing.Ct scan, colonoscopies, sonogram, etc.Came back clean.Continued having pain, diarrhea, fever at times daily.Then was finally sent for sibo testing (small intestinal bacterial overgrowth) which was confirmed.But now i'm on my 3rd course of alinia at $3000 a bottle to try and clear that up.They can not confirm this is from the surgery or the clips, but i sure didn¿t have this problem before? still suffering from sibo with daily diarrhea, pain, and restricted diet to try and relieve symptoms.My only option is to go for surgery to make sure the tissue from the clip removal isn't causing this since the went on a hunt to find the other clip and had to cut my abdominal wall to find it.I don¿t really understand why they had to put these clips in my body in the first place, i knew getting a table with me and i wasn't going to have anymore children and that's why i went to get it.Why my tubes couldn¿t have been cut and corduroys like they used to i'm not sure.I also got full reports from the hospital and found no forms in which i signed any consent to have these clips left behind in my body.That is a human violation of some kind!! i have full documentation and pictures.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER MEDICAL/FEMCARE LTD.
• MDR Report Key: 9260488
• MDR Text Key: 164837666
• Report Number: MW5090787
• 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: 10/28/2019

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 70