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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
Product CodeCAE
Regulation Number 868.5110
Device Class 1

MDR Year MDR Reports MDR Events
2019 80 80
2020 30 30
2021 62 62
2022 51 51
2023 52 52
2024 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 53 53
Inflation Problem 32 32
Deflation Problem 24 24
Break 18 18
Material Separation 17 17
Leak/Splash 15 15
Detachment of Device or Device Component 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Deformation Due to Compressive Stress 8 8
Material Integrity Problem 6 6
Physical Resistance/Sticking 6 6
Inadequacy of Device Shape and/or Size 6 6
Obstruction of Flow 6 6
Use of Device Problem 5 5
Device Damaged Prior to Use 5 5
Disconnection 5 5
Material Protrusion/Extrusion 5 5
Contamination /Decontamination Problem 5 5
Fitting Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Deformation 4 4
Material Split, Cut or Torn 4 4
Structural Problem 4 4
Material Puncture/Hole 4 4
Difficult to Insert 3 3
Material Rupture 3 3
Improper or Incorrect Procedure or Method 3 3
Loose or Intermittent Connection 3 3
Nonstandard Device 3 3
Device Handling Problem 3 3
Separation Problem 3 3
Device Dislodged or Dislocated 3 3
Device Markings/Labelling Problem 2 2
Infusion or Flow Problem 2 2
Positioning Problem 2 2
Unintended Movement 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 2 2
Delivered as Unsterile Product 2 2
Fracture 2 2
Material Fragmentation 2 2
Complete Blockage 2 2
Defective Device 2 2
Material Too Rigid or Stiff 2 2
Shipping Damage or Problem 1 1
Product Quality Problem 1 1
Malposition of Device 1 1
Dent in Material 1 1
Defective Component 1 1
Contamination 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Unintended Collision 1 1
Peeled/Delaminated 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Inaccurate Information 1 1
Unintended Deflation 1 1
Material Twisted/Bent 1 1
Output Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 148 148
No Consequences Or Impact To Patient 58 58
No Patient Involvement 24 24
Insufficient Information 20 20
No Known Impact Or Consequence To Patient 15 15
Foreign Body In Patient 6 6
Low Oxygen Saturation 5 5
Numbness 3 3
Unintended Extubation 3 3
Hypoxia 3 3
Cardiac Arrest 3 3
Airway Obstruction 3 3
Ecchymosis 2 2
Cyanosis 2 2
Death 2 2
Laceration(s) 2 2
Hypoventilation 2 2
No Code Available 2 2
Respiratory Insufficiency 2 2
Unspecified Gastrointestinal Problem 1 1
Unspecified Tissue Injury 1 1
Respiratory Arrest 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Obstruction/Occlusion 1 1
Respiratory Failure 1 1
Bronchospasm 1 1
Device Embedded In Tissue or Plaque 1 1
Abrasion 1 1
Pulmonary Edema 1 1
Ulcer 1 1
Pressure Sores 1 1
Laceration(s) of Esophagus 1 1
Extubate 1 1
Dysphagia/ Odynophagia 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Bruise/Contusion 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 May-29-2019
4 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
7 Sarnova HC, Llc II Jan-12-2024
8 SunMed Holdings, LLC II Jan-26-2023
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