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MAUDE Adverse Event Report: COOK IRELAND
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COOK IRELAND
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Catalog Number
UNKNOWN
Device Problem
Material Erosion (1214)
Patient Problem
Erosion (1750)
Event Type
Injury
Event Description
As indicated in the journal article " predictors of esophageal self-expandable metal stent migration: an academic center study", it is reported "stent erosion into broncho-pulmonary structures (confirmed by bronchoscopy and ct).".
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Manufacturer
(Section D)
COOK IRELAND
o'halloran road
national technology park
limerick
EI
MDR Report Key
9371363
MDR Text Key
167863664
Report Number
3005580113-2019-00810
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
Physician
Type of Report
Initial
Report Date
11/25/2019
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
Is the Reporter a Health Professional?
Yes
Was the Report Sent to FDA?
Yes
Date Report Sent to FDA
11/25/2019
Distributor Facility Aware Date
11/20/2019
Event Location
Hospital
Date Report to Manufacturer
11/25/2019
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
11/25/2019
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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