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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 G34110
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Kidney or Urinary Problem (4503)
Date of Event 02/22/2022
Type of Reportable Event Serious Injury
Event or Problem Description
According to the initial reporter, patient had two rms stents placed then in 8 months came back with hydronephrosis.It was further reported the patient underwent an additional procedure to replace both stents.
 
Additional Manufacturer Narrative
Common device name: fad stent, ureteral.
 
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Brand Name
RESONANCE STENT SET
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key13871080
Report Number3005580113-2022-00037
Device Sequence Number5271982
Product Code FAD
UDI-Device Identifier10827002341101
UDI-Public(01)10827002341101(17)240217(10)C1801805
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2022
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/23/2022
Report Date (Section F) 03/21/2022
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 Expiration Date02/17/2024
Device Model NumberG34110
Device Catalogue NumberRMS-060024-R
Device Lot NumberC1801805
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date02/22/2022
Event Location Hospital
Date Report to Manufacturer03/21/2022
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/23/2022
Date Device Manufactured02/17/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexFemale
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