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

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

Patient Problems Cyst(s) (1800); Menstrual Irregularities (1959); Pain (1994)

Event Type  Injury  

Event Description

I was (b)(6) y/o and very healthy when i had my tubes clamped.Now at (b)(6), i have developed cysts, and a never ending period / spotting.It is painful and stops me from having a normal, (b)(6) years old life.The older i have gotten, the worse my symptoms get.I have been begging for a reversal, but my income isn't the greatest since i still am a student.

• Brand Name: TUBAL CLAMP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 8541430
• MDR Text Key: 142958498
• Report Number: MW5086077
• 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: 04/19/2019

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 88