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

TPLC - Total Product Life Cycle
  • 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
 

New Search show TPLC since Back to Search Results
Device airway, esophageal (obturator)
Product CodeCAO
Regulation Number 868.5650
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2017 1 1
2018 2 2
2019 2 2
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 4 4
Gas/Air Leak 2 2
Human-Device Interface Problem 1 1
Material Puncture/Hole 1 1
Detachment of Device or Device Component 1 1
Deflation Problem 1 1
Disconnection 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 6 6
No Known Impact Or Consequence To Patient 1 1
Airway Obstruction 1 1
No Consequences Or Impact To Patient 1 1

-
-