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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN
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COOK IRELAND LTD UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problem Expiration Date Error (2528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2019
Event Type  malfunction  
Manufacturer Narrative
Device details are unknown.Only provided information is "zilver".Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
An expired zilver stent was placed in a patient.
 
Event Description
An expired zilver stent was placed in a patient.This report is being submitted as a cancellation report as the risk associated with this event has been determined as low.
 
Manufacturer Narrative
This file no longer meets the criteria of a malfunction report as no mdr precedence has been established for this event and the overall risk is low.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the user misreading the use by date or not checking the use by date of the device prior to implantation.
 
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Brand Name
UNKNOWN
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key9408644
MDR Text Key191320357
Report Number3001845648-2019-00664
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/06/2019
Event Location Hospital
Date Manufacturer Received11/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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