Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Model Number 80XLTCP
Medical Device Problem Code Defective Component (2292)
Health Effect - Clinical Codes Skin Tears (2516); Unspecified Tissue Injury (4559); Unintended Extubation (4564)
Date of Event 10/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the device was unable to be placed because it kept bending and caused the trachea to collapse.On re-attempting to place the device, it started to bend again and cause the trachea to collapse.The patient's vital signs dropped.Compressions and placement of a endotracheal tube were performed.The patient was taken to the operating room for an open tracheostomy.Hybrid method was used where a cut into the anatomy before performing percutaneous insertion.Patient had excessive skin breakdown on the neck as a result of the difficulty.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SHILEY
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
MDR Report Key12682961
Report Number8020889-2021-00121
Device Sequence Number17183970
Product Code JOH
UDI-Device Identifier10884522027915
UDI-Public10884522027915
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K051416
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number80XLTCP
Device Catalogue Number80XLTCP
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/04/2021
Initial Report FDA Received Date10/22/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-