MAUDE Adverse Event Report: COOK INCORPORATED COOK STENT URETERAL UNIVERSA; STENT, URETERAL

Model Number G23407

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2024

Event Type  Injury  

Event Description

Patient had a temporary ureteral stent placed on (b)(6) 2024.At that time the [invalid]was left on so the patient could remove the stent himself after discharge.Patient attempted to pull stent [invalid]on (b)(6) 2024, but patient states the [invalid] appeared to unravel, leaving the stent in place and requiring a surgical procedure on (b)(6) 2024 to remove.

• Brand Name: COOK STENT URETERAL UNIVERSA
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK INCORPORATED
• MDR Report Key: 18527014
• MDR Text Key: 333117985
• Report Number: MW5150412
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/11/2024

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 Operator: Health Professional
• Device Model Number: G23407
• Device Catalogue Number: G23407
• Device Lot Number: 15706200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White