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 2016-05-22 for FILSHIE CLIPS manufactured by Coopersurgical.

Event Text Entries

[46091908] I have been having ongoing issues with the birth control device installed within for the past eight years. In 2005, my (b)(6) doctor installed the filshie clips and the abdominal pain i reported to him. He claimed normal until scar tissue formed within a year. The pain was worse with cramps, back pain and more. In 2008, the headaches got so bad and i started having seizures. I have no family history for seizure disorders and the doctors didn't know why i had them. I still have seizures, massive pain in my lower abdomen, the mood swings, irritability all followed. My period is so heavy plus the pain of them makes it to where i can't work. I am not covered with health insurance now because after a tubal the insurance is cut off. In (b)(6) 2006, i was in a car accident that totalled my car and the pain from the clips is now unbearable i have trouble completing tasks due to the abdominal pain, the headaches, the seizures, there is so many symptoms that there isn't enough space to write it all. Please recall the clips and stop doctor's from using them. I still don't want another child but the symptoms from using this product far outweighs the risk of pregnancy. Please help me.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5062479
• MDR Report Key: 5681398
• Date Received: 2016-05-22
• Date of Report: 2016-05-22
• Date of Event: 2016-04-21
• Date Added to Maude: 2016-05-26
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: FILSHIE CLIPS
• Generic Name: FILSHIE CLIPS
• Product Code: KNH
• Date Received: 2016-05-22
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: COOPERSURGICAL

Device Sequence Number: 1

• Brand Name: FILSHIE CLIPS
• Generic Name: FILSHIE CLIPS
• Product Code: HGB
• Date Received: 2016-05-22
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOPERSURGICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2016-05-22