MAUDE Adverse Event Report: EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

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

Patient Problem Pain (1994)

Event Date 09/20/2019

Event Type  Injury  

Event Description

Back pain at the site of epidural placement after labor.Currently five months postpartum.Fda safety report id# (b)(4).

• Brand Name: EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9754208
• MDR Text Key: 181521926
• Report Number: MW5093304
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 73