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

Device Problem No Flow (2991)

Patient Problems Fatigue (1849); Headache (1880); Dizziness (2194); Diaphoresis (2452); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

Ade (adverse drug event) for fatigue, insomnia, dizziness, increase sweating and an occasional headache.He also reports one emergency room visit at the end of may when his urinary catheter quit draining.

• Brand Name: URINARY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• MDR Report Key: 17282503
• MDR Text Key: 318675040
• Report Number: MW5119206
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Male