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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Emotional Changes (1831); Menstrual Irregularities (1959); Pain (1994); Depression (2361)
Date of Event	11/22/2013
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 7299561
• Report Number: MW5075533
• Device Sequence Number: 1929216
• Product Code: KNH
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 30 YR
• Patient Weight: 75