MAUDE Adverse Event Report: COOK MEDICAL PERCUTANEOUS TRAY; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number G57717

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Item recalled per manufacturer.

• Brand Name: PERCUTANEOUS TRAY
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 16844238
• MDR Text Key: 314364877
• Report Number: MW5117148
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G57717
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1