MAUDE Adverse Event Report: COOPER SURGICAL INC. FILSHIE CLIPS

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

Patient Problems Rheumatoid Arthritis (1724); Bacterial Infection (1735); Gastritis (1874); Inflammation (1932); Pain (1994); Swelling (2091); Thyroid Problems (2102); Urinary Tract Infection (2120); Anxiety (2328); Depression (2361); Weight Changes (2607); No Code Available (3191)

Event Date 06/20/2013

Event Type  Injury  

Event Description

I had a tubal ligation with the use of filshie clips and began experiencing a host of problems afterwards including heart inflammation, rheumatoid arthritis, autoimmune thyroid disease, weight gain, adhd, severe depression and anxiety complete loss of libido, gastrointestinal issues, back pain, swollen groin, uti's, and vaginosis.I am currently seeking to have the clips removed.I was not warned about the possible side effects of the filshie clips.

• Brand Name: FILSHIE CLIPS
• Type of Device: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL INC.
• MDR Report Key: 6405659
• MDR Text Key: 70069542
• Report Number: MW5068441
• Device Sequence Number: 1
• Product Code: KNH
• 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: 03/11/2017

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID; B12; L-LYSINE; MAGNESIUM; TUMERIC; VITAMIN C; ZINC
• Patient Outcome(s): Disability
• Patient Age: 35 YR
• Patient Weight: 98