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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
MDR Year
MDR Reports
MDR Events
2018
56
56
2019
80
80
2020
30
30
2021
62
62
2022
51
51
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
47
47
Deflation Problem
40
40
Inflation Problem
32
32
Break
16
16
Detachment of Device or Device Component
13
13
Deformation Due to Compressive Stress
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Physical Resistance/Sticking
7
7
Leak/Splash
6
6
Inadequacy of Device Shape and/or Size
5
5
Material Deformation
5
5
Material Protrusion/Extrusion
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Disconnection
5
5
Device Damaged Prior to Use
5
5
Material Rupture
4
4
Obstruction of Flow
4
4
Structural Problem
4
4
Material Separation
4
4
Material Integrity Problem
3
3
Sticking
3
3
Improper or Incorrect Procedure or Method
3
3
Fitting Problem
3
3
Material Puncture/Hole
3
3
Material Split, Cut or Torn
3
3
Separation Problem
3
3
Difficult to Insert
3
3
Loose or Intermittent Connection
2
2
Malposition of Device
2
2
Device Markings/Labelling Problem
2
2
Positioning Problem
2
2
Defective Device
2
2
Insufficient Information
2
2
Device Dislodged or Dislocated
2
2
Crack
2
2
Mechanical Problem
2
2
Nonstandard Device
2
2
Device Contamination with Chemical or Other Material
2
2
Unintended Movement
2
2
Infusion or Flow Problem
2
2
Complete Blockage
2
2
Fracture
2
2
Material Fragmentation
1
1
Material Too Rigid or Stiff
1
1
Air Leak
1
1
Material Twisted/Bent
1
1
Mechanical Jam
1
1
Protective Measures Problem
1
1
Contamination
1
1
Pressure Problem
1
1
Defective Component
1
1
Dent in Material
1
1
Device-Device Incompatibility
1
1
Unintended Collision
1
1
Peeled/Delaminated
1
1
Product Quality Problem
1
1
Difficult To Position
1
1
Melted
1
1
Incorrect Measurement
1
1
Output Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Use of Device Problem
1
1
Material Perforation
1
1
Split
1
1
Unintended Deflation
1
1
Difficult to Advance
1
1
Contamination /Decontamination Problem
1
1
Difficult or Delayed Positioning
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
94
94
No Consequences Or Impact To Patient
82
82
No Patient Involvement
30
30
No Known Impact Or Consequence To Patient
27
27
Insufficient Information
8
8
Extubate
8
8
Foreign Body In Patient
5
5
No Code Available
4
4
Low Oxygen Saturation
3
3
Numbness
3
3
Airway Obstruction
3
3
Unintended Extubation
2
2
Death
2
2
Ecchymosis
2
2
Hypoxia
2
2
Pulmonary Edema
1
1
Obstruction/Occlusion
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hematoma
1
1
Hypoventilation
1
1
Unspecified Gastrointestinal Problem
1
1
Dysphagia/ Odynophagia
1
1
Ulcer
1
1
Cardiac Arrest
1
1
Laceration(s)
1
1
Pain
1
1
Discomfort
1
1
Injury
1
1
Laceration(s) of Esophagus
1
1
Bronchospasm
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
Intersurgical Inc
II
Oct-17-2022
4
King Systems Corp. dba Ambu, Inc.
II
May-29-2019
5
MEDLINE INDUSTRIES, LP - Northfield
II
Apr-14-2022
6
SunMed Holdings, LLC
II
Jan-26-2023
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