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

Device Problem Positioning Problem (3009)

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient was feeling discomfort that day after they had surgery to reposition their catheter (non-fresenius product).There was no indication that the patient's symptoms were as a results of a fresenius device, drug, or product.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS (PD) CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535596
• MDR Text Key: 321160555
• Report Number: MW5142491
• Device Sequence Number: 1
• Product Code: FJS
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1