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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 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 62 62
Inflation Problem 24 24
Leak/Splash 22 22
Material Separation 21 21
Deflation Problem 17 17
Break 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Detachment of Device or Device Component 8 8
Contamination /Decontamination Problem 8 8
Disconnection 6 6
Material Split, Cut or Torn 6 6
Use of Device Problem 6 6
Patient Device Interaction Problem 6 6
Physical Resistance/Sticking 5 5
Material Twisted/Bent 5 5
Material Puncture/Hole 5 5
Appropriate Term/Code Not Available 5 5
Pressure Problem 4 4
Structural Problem 4 4
Obstruction of Flow 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Handling Problem 3 3
Material Deformation 3 3
Material Rupture 3 3
Device Dislodged or Dislocated 3 3
Material Integrity Problem 3 3
Insufficient Information 3 3
Nonstandard Device 3 3
Failure to Deflate 3 3
Deformation Due to Compressive Stress 3 3
Separation Problem 3 3
Defective Device 2 2
Melted 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Fragmentation 2 2
Difficult to Insert 2 2
Fracture 2 2
Complete Blockage 2 2
Device Markings/Labelling Problem 2 2
Device Damaged Prior to Use 2 2
Infusion or Flow Problem 2 2
Delivered as Unsterile Product 2 2
Fitting Problem 2 2
Missing Information 1 1
Device Appears to Trigger Rejection 1 1
Inaccurate Information 1 1
Inadequacy of Device Shape and/or Size 1 1
Loose or Intermittent Connection 1 1
Unintended Collision 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 199 199
Insufficient Information 30 30
No Consequences Or Impact To Patient 9 9
Unintended Extubation 6 6
Low Oxygen Saturation 6 6
No Patient Involvement 6 6
Foreign Body In Patient 6 6
No Known Impact Or Consequence To Patient 6 6
Pain 5 5
Airway Obstruction 3 3
Hemorrhage/Bleeding 3 3
Hypoxia 3 3
Numbness 3 3
Cardiac Arrest 3 3
Ecchymosis 2 2
Laceration(s) 2 2
Hypoventilation 2 2
Respiratory Insufficiency 2 2
Cyanosis 2 2
Obstruction/Occlusion 1 1
Epistaxis 1 1
Laceration(s) of Esophagus 1 1
Erythema 1 1
Nerve Damage 1 1
Abrasion 1 1
Implant Pain 1 1
Hematoma 1 1
Unspecified Gastrointestinal Problem 1 1
Hematemesis 1 1
Bradycardia 1 1
Pulmonary Edema 1 1
Bronchospasm 1 1
Unspecified Tissue Injury 1 1
Respiratory Arrest 1 1
Ulcer 1 1
Decreased Sensitivity 1 1
Pressure Sores 1 1
Sore Throat 1 1
Death 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 Aug-06-2025
3 Intersurgical Inc II Oct-17-2022
4 King Systems Corp. dba Ambu, Inc. II Oct-30-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
6 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
9 Sarnova HC, Llc II Jan-12-2024
10 SunMed Holdings, LLC II Jan-26-2023
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