MAUDE Adverse Event Report: COOPER SURGICAL, INC. FILSHIE CLIPS AVM 851; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number LOG 389414

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 06/12/2015

Event Type  Injury  

Event Description

I was never informed that i will have metal filshie clips placed inside of me.I never consent for that and ever since there has been nothing but medical issues here on.And (b)(6) 2018 i had to undergo an add'l procedure due to filshie clips.I need them removed, but i can't afford to have them done and my insurance won't cover it, please help.What to do? it's also caused me abdominal wall mass.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS AVM 851
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL, INC.
• MDR Report Key: 9341466
• MDR Text Key: 167149453
• Report Number: MW5091158
• 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: 11/14/2019

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?: Yes
• Device Operator: No Information
• Device Model Number: LOG 389414
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 31 YR