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

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

Patient Problems Fatigue (1849); Menstrual Irregularities (1959); Muscle Spasm(s) (1966); Pain (1994); Blurred Vision (2137); Hot Flashes/Flushes (2153); Anxiety (2328); Depression (2361); Weight Changes (2607); Patient Problem/Medical Problem (2688)

Event Date 04/01/2016

Event Type  Injury  

Event Description

Filshie clips inserted (b)(6) 2016.Just a shorter sum of some of my issues, please, research these, pull them now from the market, i want them out.Hot flashes, chronic fatigue, anger, frustration, mood swings, blurred vision, irregular or heavier periods, loss of libido, increased depression and/or anxiety, achy, sore joints and/or muscles, weight gain, memory lapse, pelvic pain, increased headaches etc.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE OCCLUSION DEVICE
• Manufacturer (Section D): COOPERSURGICAL, INC
• MDR Report Key: 8293202
• MDR Text Key: 135554234
• Report Number: MW5083570
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/28/2019

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 34 YR