MAUDE Adverse Event Report: COOK INCORPORATED DAWSON MUELLER; CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY

Model Number G09706

Device Problems Leak/Splash (1354); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

Left nephrostomy tube leaking and causing decreased output.Patient taken back to interventional radiology for an exchange of the left nephrostomy tube as a result.

• Brand Name: DAWSON MUELLER
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12908067
• MDR Text Key: 281513061
• Report Number: 12908067
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/15/2021

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?: Yes
• Device Model Number: G09706
• Device Catalogue Number: ULT10.2-38-25-P-5S-CLDM-HC
• Device Lot Number: EITHER 14096276 OR 14187607
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA
• Patient Sex: Male
• Patient Weight: 63 KG