MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET

Model Number G34111

Device Problem No Flow (2991)

Patient Problem Failure of Implant (1924)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

Fad stent, ureteral.

Event 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
• MDR Text Key: 188819622
• Report Number: 3005580113-2020-00202
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)221104(10)C1664662
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 02/12/2020
• Distributor Facility Aware Date: 02/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention