MAUDE Adverse Event Report: TUBAL LIGATION; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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

Patient Problems Headache (1880); Pain (1994); Blurred Vision (2137); Depression (2361); Palpitations (2467); Heavier Menses (2666)

Event Date 02/18/2017

Event Type  Injury  

Event Description

I had an emergency c section at (b)(6) due to ruptured appendix.I asked to tie my tubes and they said ok.Since this procedure i have severe pain in my ovaries.Blood loss at period is so heavy i cannot leave the house for 6 days at least.Heart palpitations.Anxiety and depression, finally put on anti depressants and tablets to try and slow blood loss down.Sex drive is -10 and my relationship is suffering.Blurry eyes and headaches.

• Brand Name: TUBAL LIGATION
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 8281730
• MDR Text Key: 134560677
• Report Number: MW5083424
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/08/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 41