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

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

Patient Problems Emotional Changes (1831); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Thyroid Problems (2102); Depression (2361); Cognitive Changes (2551); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191)

Event Date 01/25/2015

Event Type  Injury  

Event Description

I had a tubal.I gained weight which i could not lose.Mood swing beyond this world, brain fog, manic depression, pcos, pre menopause, endometriosis.I'm only (b)(6), my periods lasted for 3 yrs, finally stopped.Big blood clots the size of a soft ball.Gallbladder problems, thyroid problems, severe bloating, stomach problems.Forgetfulness, anger, constant crying faze, gets really bad close to my periods."doctors, fda.".

• Brand Name: TUBAL LIGATION
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 8281699
• MDR Text Key: 134578494
• Report Number: MW5083422
• 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: 01/07/2019

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): Hospitalization; Other
• Patient Age: 28 YR
• Patient Weight: 76