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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL
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COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL Back to Search Results
Catalog Number EVO-20-25-15-E
Device Problem Wrong Label (4073)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2023
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) #k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Andrea called to report that the box stated the product that was ordered but the product did not match inside label was evo-20-25-12.5-e she will call back with more information andrea clarified lot c2093094.
 
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Brand Name
EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
Type of Device
ESW PROSTHESIS, ESOPHAGEAL
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer (Section G)
COOK IRELAND LTD
o halloran road
national technology park
limerick
Manufacturer Contact
sinead o'leary
o halloran road
national technology park
limerick 
MDR Report Key18325016
MDR Text Key330486258
Report Number3001845648-2023-00907
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEVO-20-25-15-E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/22/2023
Event Location Hospital
Date Manufacturer Received11/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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