MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS; TUBAL OCCLUSION DEVICE

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

Patient Problems Emotional Changes (1831); Menstrual Irregularities (1959); Pain (1994); Depression (2361)

Event Date 11/22/2013

Event Type  Injury  

Event Description

Filshie clips were used for a tubal ligation without consent.Since the procedure, i have experienced severe pain, changes in menstrual cycle, low hormones (along with its associated symptoms), emotional changes, and extreme depression.I want these removed.

• Brand Name: FILSHIE CLIPS
• Type of Device: TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 7299561
• MDR Text Key: 101143171
• Report Number: MW5075533
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 30 YR
• Patient Weight: 75