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

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

Patient Problems Hemorrhage/Bleeding (1888); Shock (2072)

Event Date 06/04/2005

Event Type  Injury  

Event Description

I had a tubal ligation after i gave birth to twins.I went into shock.The blood filled my abdomen.I needed a blood transfusion to survive.Fda safety report id# (b)(4).

• Brand Name: TUBAL LIGATION
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 11507205
• MDR Text Key: 240788944
• Report Number: MW5100071
• Device Sequence Number: 1
• Product Code: KNH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2021

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 103