MAUDE Adverse Event Report: SHILEY SHILEY FLEXIBLE TRACHEOSTOMY TUBE AND INNER CANNULA; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 6UN75H

Device Problems Nonstandard Device (1420); Improper or Incorrect Procedure or Method (2017)

Patient Problem Discomfort (2330)

Event Date 09/11/2021

Event Type  Injury  

Event Description

Recalled tracheostomy equipment implanted, (b)(6) is in and has reported to her doctors since last replacement continuous discomfort.She had seen doctors (ear, nose and throat) and was never informed of the recall.

• Brand Name: SHILEY FLEXIBLE TRACHEOSTOMY TUBE AND INNER CANNULA
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SHILEY
• MDR Report Key: 17128710
• MDR Text Key: 317233920
• Report Number: MW5118393
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6UN75H
• Device Lot Number: 22E1014JZX
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: Black Or African American