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

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

Patient Problems Nerve Damage (1979); Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Date 05/26/2016

Event Type  Injury  

Event Description

I had an emergency c section 14 months after a prior emergency c section and the gynecologist used staples following a tubal ligation.I am having nerve issues, bladder issues, suffered from a lot of health complications since my c section.I had filshie clips removed in (b)(6) of 2019 but i have a labia tear on mu right groin, and nerve damage still.My bladder functions at the age of a 14 yr old and i am (b)(6).I have had tests done on my bladder and have nerve conduction tests scheduled in the next few months also a test to try to figure out where the blood flow has been cut of they believe to my brain keeping me from getting proper circulation.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE, LTD.
• MDR Report Key: 9641498
• MDR Text Key: 176951065
• Report Number: MW5092566
• 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: 01/27/2020
• 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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 66