MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET

Model Number G34111

Device Problem Biofilm coating in Device (1062)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Fad stent, ureteral.

Event Description

According to the initial reporter: "stent placed in (b)(6) 2019 after 4 months ct performed and no hydronephrosis, so it looks as if the stent is draining.At 5 months patient became symptomatic and continues to be with "gross hematuria, urgency and urge incontinence." cystoscopy performed and distal portion of stent was encrusted and bladder is inflamed".

• Brand Name: RESONANCE STENT SET
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10029991
• MDR Text Key: 190113871
• Report Number: 3005580113-2020-00360
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)221021(10)C1661454
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2020,05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1661454
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2020
• Date Device Manufactured: 10/21/2019
• 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