MAUDE Adverse Event Report: MEDTRONIC FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Patient Problems Fever (1858); Urinary Tract Infection (2120)

Event Type  malfunction  

Event Description

Description: "ae term: urinary tract infection, fever up" additional information on the title case has been received.The urinary tract infection and fever were events related to the medtronic foley catheter used in the procedure and not to polarx.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17397228
• MDR Text Key: 319965116
• Report Number: MW5120085
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2023
• Patient Sequence Number: 1