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 Emotional Changes (1831); Fatigue (1849); Pain (1994); Thrombus (2101); Cramp(s) (2193)

Event Type  Injury  

Event Description

I thought i was getting my tubes tied.When i signed consent i was unaware i was getting a foreign object inserted in me.Since then i went from never cramping during menstrual (before tubal litigation) to now post surgery where menstrual cycles are worse than labor pains.I constantly have pelvic pains and i'm always exhausted.During my menstrual there are times i'm double over in a fetal position in tears because the pain is so unbearable and i pass clots the size of a quarter.Since the surgery i feel so depressed and feel like i will always live in pain and sadness.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: 10514610
• MDR Text Key: 206565323
• Report Number: MW5096528
• 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: 09/05/2020

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: 09/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Weight: 72