MAUDE Adverse Event Report: CATHETER; APPARATUS, SUCTION, PATIENT CARE

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2022

Event Type  Injury  

Event Description

Patient informs that he had been hospitalized for 4 days due to complications of adjusting leaking catheters from his lungs.He informs the hospitalization had nothing to do with side effects from capecitabine or his cancer.Patient held capecitabine for 4 days during hospitalization but has since returned to therapy.

• Brand Name: CATHETER
• Type of Device: APPARATUS, SUCTION, PATIENT CARE
• MDR Report Key: 15259185
• MDR Text Key: 298409197
• Report Number: MW5111604
• Device Sequence Number: 1
• Product Code: DWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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
• Treatment: CAPECITABINE
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male