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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Headache (1880); Hypersensitivity/Allergic reaction (1907); Muscle Spasm(s) (1966); Swelling (2091); Burning Sensation (2146); Dizziness (2194); Anxiety (2328); Arthralgia (2355); Reaction (2414); Weight Changes (2607)

Event Type  Injury  

Event Description

I was having a lot of pain in my right upper abdomen.After being referred to a dr for removal of my gallbladder, a date was made for my cholecystectomy surgery.The dr informed me he would be placing a metal filshie clip into my bile duct.I was alarmed and refused due to being hypersensitive to metals, particularly nickel, which i had found out through having allergy testing done, and i am positive for these allergies.After voicing my extreme anxiety and refusing the clip, in relation to any metal being implanted into my body, my dr stated there was no nickel in the device, none, just titanium, and that i would have no issue with the filshie clip.I trusted that this dr knew of my hypersensitivity and that he would not place any device containing nickel or that was a hyper allergenic metal into my body.I had no issues during surgery.I was sent home, where i developed what appeared to be an allergic reaction, with large red splotches and burning over my mid to right side of my abdomen.This lasted a few days.Within 1 year i began having similar symptoms of allergic response, but did not realize it, as i was told the clip, being the only metal i had in my body, contained no nickel.So i pushed it off.Fast forward to about 1 year and 6 months later, undeniable symptoms of allergic response to something, including pain i can point to in upper right abdomen that comes and goes often, heart palpitations, extreme fatigue, weight gain, swelling in lower knee and upper shin, left hand swelling with pain, dizziness, shortness of breath, daily headaches, joint and muscle pains and spasms etc.My symptoms drove me to look up the filshie clip, on the mfr's website.There i found info under "potential complications" that the clip may in fact contain trace amounts of nickel in the medical grade silicone, and titanium.They advise to discuss with your dr about having allergy testing done to determine hypersensitivity to nickel.I already had this testing done and knew i was hypersensitive, and related this to my (b)(6) was the dr who performed the allergy testing.(b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS INC. / FEMCARE LTD
• MDR Report Key: 8776342
• MDR Text Key: 150822196
• Report Number: MW5087979
• 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: 07/07/2019

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 38 YR
• Patient Weight: 62