MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET

Model Number	G34112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fad stent, ureteral.
Event or Problem Description
According to the initial reporter: "stent was implanted sometime in march, exact date unknown.Doing follow-up hydronephrosis (difficulty urinating) and patient has other stuff going on, and the stent was observed not draining (or not helping the kidney to drain).Doctor says the patient's condition is worse than prior to the implant.Doctor planning additional procedure for today ((b)(6) 2022) to remove the stent.".

• Brand Name: RESONANCE STENT SET
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 14495693
• Report Number: 3005580113-2022-00063
• Device Sequence Number: 5593887
• Product Code: FAD
• UDI-Device Identifier: 10827002341125
• UDI-Public: (01)10827002341125(17)241028(10)C1879495
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2022
• Report Date (Section F): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/28/2024
• Device Model Number: G34112
• Device Catalogue Number: RMS-060028-R
• Device Lot Number: C1879495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/02/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2022
• Date Device Manufactured: 10/28/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/25/2022