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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device airway, oropharyngeal, anesthesiology
Regulation Description Oropharyngeal airway.
Product CodeCAE
Regulation Number 868.5110
Device Class 1

MDR Year MDR Reports MDR Events
2020 30 30
2021 62 62
2022 51 51
2023 52 52
2024 59 59
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 51 51
Inflation Problem 19 19
Leak/Splash 17 17
Material Separation 17 17
Deflation Problem 16 16
Break 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Detachment of Device or Device Component 8 8
Disconnection 6 6
Material Split, Cut or Torn 6 6
Use of Device Problem 6 6
Material Puncture/Hole 5 5
Appropriate Term/Code Not Available 5 5
Contamination /Decontamination Problem 5 5
Structural Problem 4 4
Obstruction of Flow 4 4
Physical Resistance/Sticking 4 4
Patient Device Interaction Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Handling Problem 3 3
Material Deformation 3 3
Material Rupture 3 3
Material Integrity Problem 3 3
Device Dislodged or Dislocated 3 3
Insufficient Information 3 3
Nonstandard Device 3 3
Deformation Due to Compressive Stress 3 3
Separation Problem 3 3
Pressure Problem 3 3
Defective Device 2 2
Fracture 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Fragmentation 2 2
Difficult to Insert 2 2
Complete Blockage 2 2
Device Markings/Labelling Problem 2 2
Infusion or Flow Problem 2 2
Delivered as Unsterile Product 2 2
Fitting Problem 2 2
Missing Information 1 1
Melted 1 1
Inadequacy of Device Shape and/or Size 1 1
Inaccurate Information 1 1
Product Quality Problem 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Unintended Collision 1 1
Failure to Seal 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 168 168
Insufficient Information 25 25
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 6 6
No Patient Involvement 6 6
Unintended Extubation 6 6
Foreign Body In Patient 5 5
Pain 5 5
Low Oxygen Saturation 4 4
Cardiac Arrest 3 3
Numbness 3 3
Hypoxia 3 3
Airway Obstruction 3 3
Cyanosis 2 2
Hypoventilation 2 2
Ecchymosis 2 2
Hemorrhage/Bleeding 2 2
Respiratory Insufficiency 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Respiratory Arrest 1 1
Unspecified Gastrointestinal Problem 1 1
Hematoma 1 1
Implant Pain 1 1
Abrasion 1 1
Laceration(s) of Esophagus 1 1
Obstruction/Occlusion 1 1
Erythema 1 1
Laceration(s) 1 1
Pulmonary Edema 1 1
Bronchospasm 1 1
Unspecified Tissue Injury 1 1
Ulcer 1 1
Pressure Sores 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 Bound Tree Medical II Jul-10-2020
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
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