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

Patient Problem Urinary Tract Infection (2120)

Event Date 04/02/2024

Event Type  Injury  

Event Description

Patient's wife stated patient had a hospital visit due to a preexisting cyst on the liver, no surgery was done they just made sure everything was ok.Patient is seeing his gi doctor next week.They left the catheter for a long time on the patient and that resulted in patient getting a urinary tract infection.She states patient had been on nuplazid even at the hospital, she confirmed nothing related to the medication, the patient is taking medication as scheduled.

• Brand Name: CATHETER, RETENTION TYPE, BALLOON
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19174334
• MDR Text Key: 341079782
• Report Number: MW5154173
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 04/19/2024

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: 04/23/2024
• Patient Sequence Number: 1
• Treatment: ASPIRIN.; DULOXETINE.; IPRATROPIUM.; LEVOCETRIZINE.; LIVALO.; NEXIUM. ; NUPLAZID.; QUETIAPINE.; RIVASTIGMINE.; SINEMET.; VITAMIN C.; VITAMIN D3.
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic