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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


Premarket Reviews
ManufacturerDecision
THE LARYNGEAL MASK CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 31 31
2015 14 14
2016 69 69
2017 75 75
2018 56 56
2019 80 80
2020 30 30
2021 62 62
2022 51 51
2023 52 52
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 72 72
Gas/Air Leak 54 54
Inflation Problem 46 46
Device Operates Differently Than Expected 41 41
Break 33 33
Leak/Splash 31 31
Material Separation 26 26
Adverse Event Without Identified Device or Use Problem 14 14
Detachment of Device or Device Component 13 13
Crack 11 11
Disconnection 8 8
Material Rupture 8 8
Deformation Due to Compressive Stress 8 8
Material Deformation 7 7
Material Integrity Problem 7 7
Shelf Life Exceeded 7 7
Use of Device Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Physical Resistance/Sticking 7 7
Inadequacy of Device Shape and/or Size 6 6
Obstruction of Flow 6 6
Hole In Material 6 6
Difficult to Insert 6 6
Air Leak 6 6
Detachment Of Device Component 5 5
Device Damaged Prior to Use 5 5
Material Protrusion/Extrusion 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Contamination /Decontamination Problem 5 5
Insufficient Information 5 5
Torn Material 4 4
Material Split, Cut or Torn 4 4
Device Markings/Labelling Problem 4 4
Defective Device 4 4
Structural Problem 4 4
Sticking 4 4
Fitting Problem 4 4
Material Puncture/Hole 4 4
Loose or Intermittent Connection 4 4
Mechanical Problem 4 4
Misassembled 4 4
Nonstandard Device 3 3
Occlusion Within Device 3 3
Material Too Rigid or Stiff 3 3
Fracture 3 3
Material Fragmentation 3 3
Device Dislodged or Dislocated 3 3
Positioning Problem 3 3
Device Handling Problem 3 3
Separation Problem 3 3
Patient Device Interaction Problem 2 2
Appropriate Term/Code Not Available 2 2
Unintended Movement 2 2
Device Contamination with Chemical or Other Material 2 2
Connection Problem 2 2
Infusion or Flow Problem 2 2
Dent in Material 2 2
Malposition of Device 2 2
Kinked 2 2
Complete Blockage 2 2
Difficult to Remove 2 2
Difficult To Position 2 2
Delivered as Unsterile Product 2 2
Unintended Collision 1 1
Peeled/Delaminated 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Incorrect Measurement 1 1
Decrease in Pressure 1 1
Product Quality Problem 1 1
Component Falling 1 1
Contamination 1 1
Bent 1 1
Loss of or Failure to Bond 1 1
Burst Container or Vessel 1 1
Device Expiration Issue 1 1
Difficult or Delayed Positioning 1 1
Defective Component 1 1
Component Missing 1 1
Split 1 1
Failure to Disconnect 1 1
Material Perforation 1 1
Shipping Damage or Problem 1 1
Human-Device Interface Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
No Flow 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Output Problem 1 1
Packaging Problem 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inaccurate Information 1 1
Unintended Deflation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 154 154
No Clinical Signs, Symptoms or Conditions 143 143
No Known Impact Or Consequence To Patient 76 76
No Patient Involvement 75 75
Insufficient Information 17 17
Extubate 12 12
No Information 9 9
Foreign Body In Patient 8 8
Low Oxygen Saturation 6 6
No Code Available 6 6
Numbness 5 5
Cardiac Arrest 5 5
Death 5 5
Hypoxia 4 4
Sore Throat 4 4
Hemorrhage/Bleeding 3 3
Dysphagia/ Odynophagia 3 3
Cyanosis 3 3
Airway Obstruction 3 3
Injury 3 3
Unintended Extubation 2 2
Respiratory Insufficiency 2 2
Ecchymosis 2 2
Laceration(s) 2 2
Respiratory Failure 2 2
Device Embedded In Tissue or Plaque 2 2
Patient Problem/Medical Problem 1 1
Bronchospasm 1 1
Laceration(s) of Esophagus 1 1
Obstruction/Occlusion 1 1
Sweating 1 1
Ulcer 1 1
Pressure Sores 1 1
Discomfort 1 1
Pain 1 1
Pulmonary Edema 1 1
Respiratory Distress 1 1
Swelling 1 1
Hypoventilation 1 1
Inflammation 1 1
Hematoma 1 1
Dyspnea 1 1
Bruise/Contusion 1 1
Unspecified Gastrointestinal Problem 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Besmed Health Business Corporation II Oct-15-2018
2 Bound Tree Medical II Jul-10-2020
3 Carefusion 2200 Inc II Sep-20-2016
4 Intersurgical Inc II Oct-17-2022
5 King Systems Corp. II Jan-10-2014
6 King Systems Corp. II Oct-01-2013
7 King Systems Corp. III Sep-19-2013
8 King Systems Corp. II Nov-21-2012
9 King Systems Corp. II Apr-04-2011
10 King Systems Corp. II Mar-17-2011
11 King Systems Corp. II Jan-27-2011
12 King Systems Corp. dba Ambu, Inc. II May-29-2019
13 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2023
15 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
16 Microtek Medical Inc II Jun-26-2015
17 Sarnova HC, Llc II Jan-12-2024
18 Sterilmed Inc II Jan-13-2009
19 SunMed Holdings, LLC II Jan-26-2023
20 Teleflex Medical II Feb-10-2015
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