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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Hot Flashes/Flushes (2153); Cramp(s) (2193); Dizziness (2194); Anxiety (2328); Arthralgia (2355); Loss of consciousness (2418); Sweating (2444); Abdominal Distention (2601)

Event Date 05/11/2017

Event Type  Injury  

Event Description

I got my tubes tied with 4 filshie clips on (b)(6) 2017 during a c-section.The night of the procedure, i suffered from excessive bleeding and ended up having an overload of fluid which ended up causing fluid in my lungs.I almost choked to death, my c-section scar reopened and i was put on symbicort to fix the problem.Other issues include, 18 days of heavy bleeding during my period, all month bleeding, migraines, night sweats, fatigue, nausea, severe cramping, joint pain, pelvic pain localized to lower left abdomen, ibs, weight gain, low energy, loss of appetite, hair loss, hot flashes, loss of consciousness, bloating, increased anxiety attacks, daily cramping, dizziness, dry skin patches, hip pain, back pain, joint pain, bloating and my entire body feels extremely heavy.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 8293197
• MDR Text Key: 135565996
• Report Number: MW5083569
• 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: 01/29/2019
• 4 Devices were Involved in the Event: 1 2 3 4

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
• Device Expiration Date: 01/31/2019
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 30 YR
• Patient Weight: 68