FILSHIE CLIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-11 for FILSHIE CLIPS manufactured by .

Event Text Entries

[20984539] On (b)(6) 2013, i had a tubal ligation done with filshie clips, in which i was not aware of. I have been in pain every since, for the past 18 months. I have been to the er several times for lower back pains, extreme fatigue, extreme lower abdominal pains on both sides, extreme headaches, excessive bleeding during periods, extreme insomnia, getting sick now almost everyday for no apparent reason. Before the tubal with these clips, my health was perfect. I never experienced anything like this after my first two births. Doctors are overlooking this as being all in my head as well as others, something needs to be done about this nationwide. I am in pain now. I recently started to have a new symptom. I now have chest pains. I had an ekg done. It is not my heart, something has to be done immediately about these clips. They migrate and cause health problems that can't keep getting overlooked.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5032763
• MDR Report Key: 3470064
• Date Received: 2013-11-11
• Date of Report: 2013-11-07
• Date of Event: 2013-09-19
• Date Added to Maude: 2013-11-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FILSHIE CLIPS
• Generic Name: TUBAL OCCLUSION
• Product Code: HGB
• Date Received: 2013-11-11
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Deathisabilit	2013-11-11