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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Event Description

Patient reported being sick since her catheter was put in and her kidneys are failing.Patient is not sure it¿s an infection.No further information provided.Patient does not consent to be contacted.If a reporter doesn¿t consent for manufacturer.Follow up.

• Brand Name: CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16684174
• MDR Text Key: 312935311
• Report Number: MW5116366
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/31/2023

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2023
• Patient Sequence Number: 1
• Treatment: ABBVIE.; HUMIRA PEN 40 MG/0.4 ML NO CITR/ 40 MG/0.4.
• Patient Age: 66 YR
• Patient Sex: Female