MAUDE Adverse Event Report: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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

Patient Problems Immunodeficiency (2156); Arthralgia (2355); Heavier Menses (2666)

Event Date 02/12/2014

Event Type  Injury  

Event Description

Had tubal performed following a c section.No device tubal parkland method.Extreme blood loss during menstruation, joint pain, immune condition, clots.Allergies: iron.Fda safety report id# (b)(4).

• Brand Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 9695317
• MDR Text Key: 179108531
• Report Number: MW5092932
• 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: 02/06/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Weight: 78