MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

Common name: esw prosthesis, esophageal.Procode: esq.

Event Description

"adverse events occurred in 6/14 (42.9%) patients with a malignant fistula and in 4/11 (36.4%) patients with a benign fistula.1 case of pneumonia.".

• Brand Name: UNKNOWN
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9483567
• MDR Text Key: 185223855
• Report Number: 3005580113-2019-00913
• 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

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• 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): Hospitalization; Required Intervention