MAUDE Adverse Event Report: COOK MEDICAL RESONANCE METALLIC URETERAL STENT SET; STENT, URETERAL

Model Number G34111

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Event Description

Left metallic stent insertion.Outside of sealed box stated 6f x 24cm.It was noted that the inside packaging label stated 6f x 26cm.Provider states the size was appropriate for the patients and believes the label had incorrect number inside the packaging.

• Brand Name: RESONANCE METALLIC URETERAL STENT SET
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK MEDICAL; 1025 acuff road; bloomington IN 47404
• MDR Report Key: 19142438
• MDR Text Key: 340585382
• Report Number: 19142438
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2023,12/18/2023

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: G34111
• Device Catalogue Number: G34111
• Device Lot Number: C1984697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female