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: MALLINCKRODT MEDICAL SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)
  • 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
 

MALLINCKRODT MEDICAL SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR) Back to Search Results
Model Number 86551
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Code Extubate (2402)
Date of Event 11/13/2019
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 had cuff breakage.Oro tracheal tube change was performed, removed and was intubated.The patient was admitted to surgery recovery room, conscious, alert with good respiratory pattern under residual effects of general anesthesia with oxygen support.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SHILEY
Common Device Name
TUBE, TRACHEAL (W/WO CONNECTOR)
Manufacturer (Section D)
MALLINCKRODT MEDICAL
cornamaddy
athlone 3810
MDR Report Key9410925
Report Number8020889-2019-00167
Device Sequence Number2305880
Product Code BTR
UDI-Device Identifier20884521211671
UDI-Public20884521211671
Combination Product (Y/N)N
Initial Reporter CountryCO
PMA/510(K) Number
K790575
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/04/2019
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 Expiration Date12/01/2023
Device Model Number86551
Device Catalogue Number86551
Device Lot Number201812067X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/15/2019
Initial Report FDA Received Date12/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age62 YR
-
-