MAUDE Adverse Event Report: COOK INCORPORATED COOK MEDICAL UNIVERSE; STENT, URETERAL

Model Number G49901

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The provider placed frim ureteral stent near end of operating room case, and found it to be defective.Stent then explanted, and new stent then implanted.Fda safety report id# (b)(4).

• Brand Name: COOK MEDICAL UNIVERSE
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK INCORPORATED; bloomington IN 47404
• MDR Report Key: 8822101
• MDR Text Key: 152221201
• Report Number: MW5088319
• 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: Other
• Type of Report: Initial
• Report Date: 07/19/2019

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 Expiration Date: 03/28/2022
• Device Model Number: G49901
• Device Catalogue Number: UFH-500-R
• Device Lot Number: 9627273
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 45