MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET

Model Number	G34111
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fad stent, ureteral.
Event or Problem Description
As initially reported to customer relations via email from customer to district manager: the metal stands we recently placed are not draining.She is back on nephrostomy drainage.

• Brand Name: RESONANCE STENT SET
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9701564
• Report Number: 3005580113-2020-00202
• Device Sequence Number: 14024375
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)221104(10)C1664662
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2020
• Report Date (Section F): 02/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1664662
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 02/12/2020