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

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

Patient Problems Anemia (1706); Pain (1994); Blood Loss (2597); Heavier Menses (2666)

Event Date 06/14/2013

Event Type  Injury  

Event Description

I had my 3rd child via cesarean section in 2008 and they used filshie clips to block my tubes.Since then i've had heavy and painful periods.They got so bad i became severely anemic and needed a blood transfusion in 2016 but i opted out and decided to take an iron supplement with vitamin c for better absorption.Then i was placed on camrese birth control pill so i would have my period 4 times a year and not loose so much blood and be in pain.I have doing research and i'm pretty sure i have ptls.I hope to get them removed.Fda safety report id# (b)(4).

• Brand Name: FILSHIE
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD
• MDR Report Key: 9128716
• MDR Text Key: 160420502
• Report Number: MW5090065
• 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: 09/17/2019

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: 09/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CAMRESE; IRON ; VIT C; ZOLOFT
• Patient Outcome(s): Disability
• Patient Age: 21 YR