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

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

Patient Problems Cyst(s) (1800); Emotional Changes (1831); Headache (1880); Weight Changes (2607); Heavier Menses (2666); Fluid Discharge (2686)

Event Date 09/12/2010

Event Type  Injury  

Event Description

I had a tubal ligation during a c-section on (b)(6) 2010.The dr removed my fimbria but ever since then i have horrible periods, a lot of blood clots, no sex drive, had leaking breast for a while, headaches all the time, mood swings, dry vaginal, can't orgasm naturally, can't lose weight naturally, get cyst on ovaries every month.

• Brand Name: TUBAL LIGATION
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 8231859
• MDR Text Key: 132798825
• Report Number: MW5083014
• 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: 01/06/2019

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 25 YR
• Patient Weight: 77