MAUDE Adverse Event Report: COOPERSURGICAL, INC. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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

Patient Problems Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Breast Discomfort/Pain (4504); Menorrhagia (4508)

Event Date 07/01/2015

Event Type  Injury  

Event Description

Shortly after my tubal ligation, i began having severe bleeding during my menstrual cycles.My period started becoming very irregular and extremely painful.I started having breast tenderness a week before my period would start.My cycle would come every 2 weeks and then not at all for 6-8 weeks.It remained like this for years.Now i am experiencing spotting a week before my period should start for 2 days then nothing.And then a regular cycle lasting 4-9 days; sometimes longer.I am extremely nauseous during my cycle and nothing helps the pain.I've never dealt with these issues before my tubal.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPERSURGICAL, INC. ; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 11805881
• MDR Text Key: 250220961
• Report Number: MW5101274
• Device Sequence Number: 1
• Product Code: KNH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/06/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 28 YR
• Patient Weight: 78