• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK IRELAND LTD UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problem Migration (4003)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Common name: esw prosthesis, esophageal.Procode: esq.
 
Event Description
As reported in the journal article silon et al 2017-"endoscopic management of esophagorespiratory fistulas: a multicenter retrospective study of techniques and outcomes"."stent migration with subsequent aspiration".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key9483585
MDR Text Key188748705
Report Number3005580113-2019-00912
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/17/2019
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 Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/17/2019
Distributor Facility Aware Date12/04/2019
Event Location Hospital
Date Report to Manufacturer12/17/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-