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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 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 53 53
Inflation Problem 28 28
Deflation Problem 23 23
Break 18 18
Material Separation 17 17
Leak/Splash 11 11
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
Device Damaged Prior to Use 5 5
Disconnection 5 5
Material Protrusion/Extrusion 5 5
Contamination /Decontamination Problem 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Material Deformation 4 4
Material Split, Cut or Torn 4 4
Fitting Problem 4 4
Structural Problem 4 4
Use of Device Problem 4 4
Material Puncture/Hole 4 4
Difficult to Insert 3 3
Improper or Incorrect Procedure or Method 3 3
Material Rupture 3 3
Loose or Intermittent Connection 3 3
Nonstandard Device 3 3
Separation Problem 3 3
Device Handling Problem 3 3
Patient Device Interaction Problem 2 2
Unintended Movement 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Device Dislodged or Dislocated 2 2
Positioning Problem 2 2
Infusion or Flow Problem 2 2
Device Markings/Labelling Problem 2 2
Delivered as Unsterile Product 2 2
Fracture 2 2
Material Fragmentation 2 2
Complete Blockage 2 2
Defective Device 2 2
Malposition of Device 1 1
Dent in Material 1 1
Defective Component 1 1
Shipping Damage or Problem 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 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
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Advance 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Output Problem 1 1
Material Twisted/Bent 1 1
Inaccurate Information 1 1
Unintended Deflation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 140 140
No Consequences Or Impact To Patient 58 58
No Patient Involvement 24 24
Insufficient Information 17 17
No Known Impact Or Consequence To Patient 15 15
Foreign Body In Patient 6 6
Low Oxygen Saturation 5 5
Unintended Extubation 3 3
Hypoxia 3 3
Numbness 3 3
Airway Obstruction 3 3
Ecchymosis 2 2
Cardiac Arrest 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 Failure 1 1
Bronchospasm 1 1
Device Embedded In Tissue or Plaque 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pulmonary Edema 1 1
Obstruction/Occlusion 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
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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