MAUDE Adverse Event Report: AORTIC VALVE; HEART-VALVE, MECHANICAL

Device Problem Use of Device Problem (1670)

Patient Problems Unspecified Infection (1930); Urinary Tract Infection (2120)

Event Date 11/15/2022

Event Type  Injury  

Event Description

The pt had her aortic valve replaced on (b)(6) 2022.Approx (b)(6) 2022 it got infected.She completed 6 weeks of iv antibiotics.Infection is cleared.Then (b)(6) 2013 she contacted a urinary tract infection.It is cleared now.She has not taken orencia since b)(6).

• Brand Name: AORTIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• MDR Report Key: 16610674
• MDR Text Key: 312026521
• Report Number: MW5115954
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): Y
• 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: 03/21/2023

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?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2023
• Patient Sequence Number: 1
• Treatment: ORENCIA
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female