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TPLC
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show TPLC since
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Device
airway, oropharyngeal, anesthesiology
Product Code
CAE
Regulation Number
868.5110
Device Class
1
Premarket Reviews
Manufacturer
Decision
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
Deformation Due to Compressive Stress
8
8
Disconnection
8
8
Use of Device Problem
8
8
Material Rupture
8
8
Physical Resistance/Sticking
7
7
Improper or Incorrect Procedure or Method
7
7
Material Integrity Problem
7
7
Material Split, Cut or Torn
7
7
Shelf Life Exceeded
7
7
Material Deformation
7
7
Insufficient Information
6
6
Air Leak
6
6
Obstruction of Flow
6
6
Difficult to Insert
6
6
Inadequacy of Device Shape and/or Size
6
6
Hole In Material
6
6
Contamination /Decontamination Problem
5
5
Detachment Of Device Component
5
5
Material Protrusion/Extrusion
5
5
Appropriate Term/Code Not Available
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Device Damaged Prior to Use
5
5
Structural Problem
4
4
Sticking
4
4
Misassembled
4
4
Material Too Rigid or Stiff
4
4
Device Dislodged or Dislocated
4
4
Fitting Problem
4
4
Defective Device
4
4
Loose or Intermittent Connection
4
4
Material Puncture/Hole
4
4
Mechanical Problem
4
4
Device Markings/Labelling Problem
4
4
Torn Material
4
4
Material Fragmentation
3
3
Fracture
3
3
Nonstandard Device
3
3
Separation Problem
3
3
Positioning Problem
3
3
Device Handling Problem
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
Hemorrhage/Bleeding
4
4
Sore Throat
4
4
Hypoxia
4
4
Unintended Extubation
3
3
Airway Obstruction
3
3
Dysphagia/ Odynophagia
3
3
Injury
3
3
Cyanosis
3
3
Laceration(s)
2
2
Ecchymosis
2
2
Hypoventilation
2
2
Respiratory Insufficiency
2
2
Respiratory Failure
2
2
Device Embedded In Tissue or Plaque
2
2
Abrasion
1
1
Swelling
1
1
Laceration(s) of Esophagus
1
1
Obstruction/Occlusion
1
1
Discomfort
1
1
Hematoma
1
1
Dyspnea
1
1
Pain
1
1
Inflammation
1
1
Bronchospasm
1
1
Pulmonary Edema
1
1
Unspecified Tissue Injury
1
1
Respiratory Arrest
1
1
Ulcer
1
1
Unspecified Gastrointestinal Problem
1
1
Respiratory Distress
1
1
Sweating
1
1
Pressure Sores
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Patient Problem/Medical Problem
1
1
Bruise/Contusion
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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