MAUDE Adverse Event Report: PERITONEAL DIALYSIS (PD); CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problem No Flow (2991)

Patient Problem Discomfort (2330)

Event Type  Other  

Event Description

On (b)(6) 2023, during a follow up call, a peritoneal dialysis (pd) patient stated he couldn't drain and it was hurting.Patient was hospitalized on (b)(6) 2023.He had x-rays and it seemed the catheter moved.Patient is currently doing hd 3 times a week and then will go back to pd.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS (PD)
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• MDR Report Key: 17298090
• MDR Text Key: 318779242
• Report Number: MW5119248
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1