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

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Ae for catheter was leaking.Husband attempted to contact home health and they were unavailable.Took to emergency room and they fixed it.Refer to additional documents in i2k.

• Brand Name: CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• MDR Report Key: 17254742
• MDR Text Key: 318464259
• Report Number: MW5119102
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• 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: Female