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

Patient Problems Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/04/2024

Event Type  Injury  

Event Description

Per pt's wife, she reported that he went to the er for uti about a month ago (she was not sure of exact dates), she stated that they did admit him to the hospital for about 3 days due to him having a-fib and tested positive for covid as well.He completed his course of cipro and is feeling better now, no other new meds were added, no other issues to report.She stated that he has a foley catheter so he gets uti's often.

• Brand Name: FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19042356
• MDR Text Key: 339506824
• Report Number: MW5153539
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 04/02/2024

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: 04/03/2024
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 MG.; ATORVASTATIN.; CARBIDOPA/LEVODOPA.; METOPROLOL ER.; NUPLAZID.; TYLENOL.; VITAMIN D3.; XARELTO.
• Patient Outcome(s): Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male