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MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN
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COOK IRELAND LTD UNKNOWN
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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".
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Brand Name
UNKNOWN
Manufacturer
(Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key
9483585
MDR Text Key
188748705
Report Number
3005580113-2019-00912
Device Sequence Number
1
Product Code
ESW
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
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 Number
UNKNOWN
Device Lot Number
UNKNOWN
Was Device Available for Evaluation?
No
Was the Report Sent to FDA?
Yes
Date Report Sent to FDA
12/17/2019
Distributor Facility Aware Date
12/04/2019
Event Location
Hospital
Date Report to Manufacturer
12/17/2019
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
12/17/2019
Is the Device Single Use?
Yes
Is This a Reprocessed and Reused Single-Use Device?
No
Type of Device Usage
Initial
Patient Sequence Number
1
Patient Outcome(s)
Required Intervention;
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