MAUDE Adverse Event Report: UNKNOWN CATHETER; CATHETER, RETENTION TYPE, BALLOON

Patient Problem Urinary Tract Infection (2120)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Patient reported hospitalized due to catheter leaking and had urinary tract infection last year but couldn't remember when it occurred.Only advised treated with iv antibiotics and released and no further issues noted.Patient noted had 2 relapses/exacerbations in last year but resolved and continued therapy.Currently has no active ms symptoms.

• Brand Name: CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17586282
• MDR Text Key: 321733929
• Report Number: MW5144797
• 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: 08/16/2023

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: 08/18/2023
• Patient Sequence Number: 1
• Treatment: GILENYA CAP 0.5MG.NDC# OR UNIQUE ID: (B)(6).; NOVARTIS.LOT# NA.
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female