MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Peritonitis (2252)

Event Type  Injury  

Event Description

On an unreported date, the patient experienced an infection on the exit site.The patient experienced and was hospitalized for peritonitis.The cause of peritonitis was an infection on the exit site.Four days later, the patient was discharged from the hospital.Product surveillance spoke with the peritoneal dialysis nurse (pdrn) who stated that she does not have the information about the catheter, including the manufacturer.This information is unknown.No further information was provided.Patient injury reported: yes.Medical intervention required: yes.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERITONEAL
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531597
• MDR Text Key: 321082914
• Report Number: MW5138510
• Device Sequence Number: 1
• Product Code: GBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1