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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET
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COOK IRELAND LTD RESONANCE STENT SET Back to Search Results
Model Number G34111
Medical Device Problem Code Biofilm coating in Device (1062)
Health Effect - Clinical Code Swelling (2091)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Fad stent, ureteral.
 
Event or Problem 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".
 
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Brand Name
RESONANCE STENT SET
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key10029991
Report Number3005580113-2020-00360
Device Sequence Number17114155
Product Code FAD
UDI-Device Identifier10827002341118
UDI-Public(01)10827002341118(17)221021(10)C1661454
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/06/2020
Report Date (Section F) 05/05/2020
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 Date10/21/2022
Device Model NumberG34111
Device Catalogue NumberRMS-060026-R
Device Lot NumberC1661454
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/27/2020
Event Location Hospital
Date Report to Manufacturer05/05/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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