MAUDE Adverse Event Report: KENDALL GAMMATRON, THAILAND TRACHEOSTOMY TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number 8670

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 03/31/2014

Event Type  Injury  

Manufacturer Narrative

Title unanticipated difficult nasotracheal extubation following oral surgery source acta anaesthesiologica taiwanica volume 52, 2014 (197-200).If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, postoperatively, the patient had unexpected postoperative difficult nasotracheal extubation by a kirschner pin and penetrated the tube and fixing the tube at the maxillary bone following tumor resection.

• Brand Name: TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): KENDALL GAMMATRON, THAILAND; nakhon chai si district; nakhon pathom ; TH
• Manufacturer (Section G): KENDALL GAMMATRON, THAILAND; nakhon chai si district; nakhon pathom ; TH
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8973405
• MDR Text Key: 157112914
• Report Number: 8040459-2019-00095
• Device Sequence Number: 1
• Product Code: BTR
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K051416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8670
• Device Catalogue Number: 8670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention