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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 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 73 73
Gas/Air Leak 57 57
Inflation Problem 51 51
Device Operates Differently Than Expected 41 41
Leak/Splash 38 38
Break 33 33
Material Separation 26 26
Adverse Event Without Identified Device or Use Problem 15 15
Detachment of Device or Device Component 13 13
Crack 11 11
Disconnection 8 8
Deformation Due to Compressive Stress 8 8
Material Rupture 8 8
Use of Device Problem 8 8
Material Split, Cut or Torn 7 7
Improper or Incorrect Procedure or Method 7 7
Shelf Life Exceeded 7 7
Physical Resistance/Sticking 7 7
Material Integrity Problem 7 7
Material Deformation 7 7
Hole In Material 6 6
Air Leak 6 6
Difficult to Insert 6 6
Inadequacy of Device Shape and/or Size 6 6
Insufficient Information 6 6
Obstruction of Flow 6 6
Detachment Of Device Component 5 5
Appropriate Term/Code Not Available 5 5
Contamination /Decontamination Problem 5 5
Device Damaged Prior to Use 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Material Protrusion/Extrusion 5 5
Loose or Intermittent Connection 4 4
Fitting Problem 4 4
Device Dislodged or Dislocated 4 4
Material Too Rigid or Stiff 4 4
Misassembled 4 4
Structural Problem 4 4
Torn Material 4 4
Device Markings/Labelling Problem 4 4
Material Puncture/Hole 4 4
Mechanical Problem 4 4
Defective Device 4 4
Sticking 4 4
Nonstandard Device 3 3
Separation Problem 3 3
Fracture 3 3
Material Fragmentation 3 3
Positioning Problem 3 3
Occlusion Within Device 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 161 161
No Consequences Or Impact To Patient 154 154
No Known Impact Or Consequence To Patient 76 76
No Patient Involvement 75 75
Insufficient Information 24 24
Extubate 12 12
No Information 9 9
Foreign Body In Patient 8 8
Low Oxygen Saturation 6 6
No Code Available 6 6
Cardiac Arrest 6 6
Death 5 5
Numbness 5 5
Sore Throat 4 4
Hemorrhage/Bleeding 4 4
Hypoxia 4 4
Cyanosis 3 3
Unintended Extubation 3 3
Airway Obstruction 3 3
Dysphagia/ Odynophagia 3 3
Injury 3 3
Device Embedded In Tissue or Plaque 2 2
Respiratory Failure 2 2
Respiratory Insufficiency 2 2
Laceration(s) 2 2
Ecchymosis 2 2
Hypoventilation 2 2
Dyspnea 1 1
Discomfort 1 1
Swelling 1 1
Pain 1 1
Obstruction/Occlusion 1 1
Pulmonary Edema 1 1
Bronchospasm 1 1
Unspecified Tissue Injury 1 1
Laceration(s) of Esophagus 1 1
Ulcer 1 1
Abrasion 1 1
Inflammation 1 1
Pressure Sores 1 1
Hematoma 1 1
Unspecified Gastrointestinal Problem 1 1
Respiratory Arrest 1 1
Respiratory Distress 1 1
Sweating 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bruise/Contusion 1 1
Patient Problem/Medical Problem 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 II Sep-06-2024
14 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2023
16 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
17 Microtek Medical Inc II Jun-26-2015
18 Sarnova HC, Llc II Jan-12-2024
19 Sterilmed Inc II Jan-13-2009
20 SunMed Holdings, LLC II Jan-26-2023
21 Teleflex Medical II Feb-10-2015
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