MAUDE Adverse Event Report: COVIDIEN LLC SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	8LPC
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Two pressure injuries developed under the faceplate of the tracheostomy.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7901399
• Report Number: 7901399
• Device Sequence Number: 16502325
• Product Code: JOH
• UDI-Device Identifier: 60884522007141
• UDI-Public: (01)60884522007141
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/15/2018
• Report Date (Section F): 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8LPC
• Device Catalogue Number: 8LPC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 09/07/2018