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, oropharyngeal, anesthesiology
Regulation Description Oropharyngeal airway.
Product CodeCAE
Regulation Number 868.5110
Device Class 1

MDR Year MDR Reports MDR Events
2021 62 63
2022 51 51
2023 52 52
2024 59 59
2025 61 61
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 59 59
Inflation Problem 30 30
Leak/Splash 25 25
Material Separation 21 21
Deflation Problem 19 19
Break 14 14
Adverse Event Without Identified Device or Use Problem 10 10
Patient Device Interaction Problem 8 8
Contamination /Decontamination Problem 7 7
Use of Device Problem 7 7
Material Split, Cut or Torn 6 7
Collapse 6 6
Appropriate Term/Code Not Available 5 5
Physical Resistance/Sticking 5 5
Detachment of Device or Device Component 5 5
Material Twisted/Bent 5 5
Disconnection 4 4
Pressure Problem 4 4
Material Puncture/Hole 4 4
Material Deformation 4 4
Obstruction of Flow 4 4
Failure to Deflate 3 3
Separation Problem 3 3
Nonstandard Device 3 3
Device Dislodged or Dislocated 3 3
Device Handling Problem 3 3
Material Rupture 3 3
Unintended Deflation 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 3 3
Material Fragmentation 3 3
Structural Problem 3 3
Deformation Due to Compressive Stress 2 2
Melted 2 2
Fracture 2 2
Delivered as Unsterile Product 2 2
Infusion or Flow Problem 2 2
Difficult to Insert 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Defective Device 2 2
Insufficient Information 2 2
Device Markings/Labelling Problem 2 2
Device Damaged Prior to Use 2 2
Fitting Problem 2 2
Dent in Material 1 1
Material Too Rigid or Stiff 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Shipping Damage or Problem 1 1
Defective Component 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 213 213
Insufficient Information 39 39
Foreign Body In Patient 7 7
Unintended Extubation 6 6
Pain 5 5
Hypoxia 5 5
Low Oxygen Saturation 5 5
Cardiac Arrest 3 4
Laceration(s) 3 3
Hemorrhage/Bleeding 3 3
Cyanosis 2 2
Hypoventilation 2 2
Abrasion 2 2
Ecchymosis 2 2
Pulmonary Edema 2 2
Respiratory Insufficiency 2 2
Airway Obstruction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Decreased Sensitivity 1 1
Respiratory Arrest 1 1
Unspecified Gastrointestinal Problem 1 1
Hematoma 1 1
Implant Pain 1 1
Laceration(s) of Esophagus 1 1
Obstruction/Occlusion 1 1
Epistaxis 1 1
Erythema 1 1
Nerve Damage 1 1
Hematemesis 1 1
Bradycardia 1 1
Bronchospasm 1 1
Unspecified Tissue Injury 1 1
Ulcer 1 1
Pressure Sores 1 1
Sore Throat 1 1
Respiratory Failure 1 1
Bruise/Contusion 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Intersurgical Inc II Aug-06-2025
2 Intersurgical Inc II Oct-17-2022
3 King Systems Corp. dba Ambu, Inc. II Oct-30-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
5 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
8 Sarnova HC, Llc II Jan-12-2024
9 SunMed Holdings, LLC II Jan-26-2023
-
-