MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN

Catalog Number UNKNOWN

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Common device name: fad stent, ureteral.

Event Description

According to the initial reporter, the resonance stent was noted to be occluded.Hydronephrosis was noted in the left kidney.The stent was removed with cystoscopic graspers and a plastic stent was placed.Further information provided indicates, the patient had two failed 6x24 resonance stents in her left ureter that were replaced with two more 6x24 resonance stents.Indwelling time is approximately 6 months.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11791799
• MDR Text Key: 261545570
• Report Number: 3005580113-2021-00061
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention