FILSHIE CLIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-14 for FILSHIE CLIP manufactured by .

Event Text Entries

[31576828] I had a tubal ligation in 2008. Since then i have been going back and fourth to the doctor for severe pain and menstrual bleeding that i now have to take the depo shot to control otherwise i will bleed to death. I tried to get a tubal reversal and found out they used filshie clips. I wasn't aware of them being used; i found out when i requested my pathological report. I am currently still in pain. I have been given birth control after birth control and pain medicine which can mess up your organs 7 years later. I would love to get the filshie clips removed due to pain, etc. Nothing was done, they offered hysterectomy and burning of the uterus but i refused, they also offered more birth control when i have told them numerous times that i was okay until i got the tubal ligation, it's all in my medical records.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5057950
• MDR Report Key: 5235249
• Date Received: 2015-11-14
• Date of Report: 2015-11-14
• Date of Event: 2008-06-12
• Date Added to Maude: 2015-11-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• 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: 3

Device Sequence Number: 0

• Brand Name: FILSHIE CLIP
• Generic Name: FILSHIE CLIP
• Product Code: KNH
• Date Received: 2015-11-14
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0

Device Sequence Number: 1

• Brand Name: FILSHIE CLIP
• Generic Name: FILSHIE CLIP
• Product Code: HGB
• Date Received: 2015-11-14
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-11-14