MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Naturally Worn (2988)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Event Description

It was originally reported by a consumer that a patient had experienced peritonitis.It was later clarified by a nurse that the patient went to the hospital in (b)(6) 2012 because her pd catheter had wear and tear holes from the patient bending and taping her pd catheter.The patient did not experience peritonitis and was treated prophylactically with unspecified antibiotics.The patient was told not to bend and tape her pd catheter.In (b)(6) 2012, the patient was diagnosed with a hernia.The nurse confirmed that the patient was supposed to have a hernia repair in (b)(6)2012, but did not because the patient experienced too high of a blood pressure.The patient underwent a hernia repair on an unknown date in (bn)(6)2012.On an unreported date, the patient recovered from the events.Dianeal therapy was ongoing.Per the nurse, the events were unrelated to dianeal therapy.No information was available as to the product name, manufacturer, product code, or lot number of the catheter involved in this event.Patient injury reported: 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: 17531120
• MDR Text Key: 321137713
• Report Number: MW5138035
• 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: 02/18/2013

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