MAUDE Adverse Event Report: Cook Inc UNIVERSA SOFT URETERAL STENT SET; FAD Stent, Ureteral

Model Number	G49941
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD Stent, Ureteral
• Manufacturer (Section D): Cook Inc; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; +1(812)339-2235
• MDR Report Key: 50809176
• Report Number: 1820334-2026-00985
• Device Sequence Number: 8597190
• Product Code: FAD
• UDI-Device Identifier: 00827002499416
• UDI-Public: (01)00827002499416(17)290211(10)16986075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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
• Operator of Device: Health Professional
• Device Model Number: G49941
• Device Catalogue Number: USH-624
• Device Lot Number: 16986075
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 09/19/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown