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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
2021 62 63
2022 51 51
2023 52 52
2024 59 59
2025 61 61
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 58 58
Inflation Problem 26 26
Leak/Splash 23 23
Material Separation 20 20
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
Material Twisted/Bent 5 5
Disconnection 4 4
Pressure Problem 4 4
Detachment of Device or Device Component 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
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
Nonstandard Device 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 207 207
Insufficient Information 38 38
Foreign Body In Patient 6 6
Unintended Extubation 6 6
Pain 5 5
Low Oxygen Saturation 5 5
Cardiac Arrest 3 4
Laceration(s) 3 3
Hypoxia 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
Unspecified Gastrointestinal Problem 1 1
Respiratory Arrest 1 1
Hematoma 1 1
Implant Pain 1 1
Obstruction/Occlusion 1 1
Laceration(s) of Esophagus 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
Device Embedded In Tissue or Plaque 1 1
Bruise/Contusion 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
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