MAUDE Adverse Event Report: FEMCARE, LTD. FILSHIE CLIPS; LAPROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Reaction (1733); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Rash (2033); Swelling (2091); Dizziness (2194); Myalgia (2238); Arthralgia (2355); Palpitations (2467)

Event Type  Injury  

Event Description

I had a tubal ligation (b)(6) 2012.During my c-section, filshie clips were used (2 on each tube).Pain in pelvic area followed, not the same pain as i¿ve experienced with my previous cc-sections.A week post op my throat swelled up and i went to the er, for 7 years i have suffered.To name a few- allergic type symptoms, dizziness, heart palpitations, muscle and joint pains, a rash (biopsy showed something in my body causing this), new allergies to any metals, pelvic pain, inflammation, swelling of the abdomen, migraines, autoimmune type symptoms and about 15 more symptoms.For years i¿ve had labs and all test which come back normal.I was healthy prior to these clips being placed.I was not told filshie clips were used, i only found out 3 months ago after having a x-ray from my chiropractor.The 4 clips are still in my body.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE, LTD.
• MDR Report Key: 9694024
• MDR Text Key: 179294190
• Report Number: MW5092902
• Device Sequence Number: 2
• 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: 02/06/2020
• 2 Devices were Involved in the Event: 1 2

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: 02/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 77