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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Pain (1994); Burning Sensation (2146); Tingling (2171); Urticaria (2278); Arthralgia (2355); Abdominal Distention (2601)

Event Date 09/22/2016

Event Type  Injury  

Event Description

I had filshie clips implanted during my c-section in 2016.The doctor used 4 of them for a tubal ligation.I was not tested for an allergy to titanium, nickel, or silicone.I have a known allergy to nickel.The clips set off an autoimmune response in my body causing ibs, bloating , severe and persistent abdominal pain, hives, dermographia, tingling in my hands and feet, burning in my hands and feet, joint pain, hair loss, acne, hormonal issues, brain fog, and fatigue.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL INC.
• MDR Report Key: 8231588
• MDR Text Key: 132903450
• Report Number: MW5082988
• 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: 01/07/2019

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 81