MAUDE Adverse Event Report: FEMCARE-NIKOMED LTD FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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

Patient Problems Inflammation (1932); Pain (1994); Dyspareunia (4505)

Event Date 08/06/1999

Event Type  Injury  

Event Description

On (b)(6) 2009 my tubes were tied and filshie clamps were placed on my tubes.I have suffered horrible stomach pain since.The clamps keep my uterus so inflamed that i actually tested positive for high grade uterine cancer.I had to have a biopsy which showed it was actually inflammation.Sex is extremely painful.I've had to undergo laparoscopies due to the constant pain.The pain has become so unbearable that i have started researching doctors to take the clamps out.I had back surgery where they drilled 2 of my spinal discs out & that pain was nowhere near as bad as all the pain i've suffered from these clips.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE-NIKOMED LTD
• MDR Report Key: 10540908
• MDR Text Key: 207372500
• Report Number: MW5096668
• 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: 09/13/2020

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: 09/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Weight: 73