Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
airway, oropharyngeal, anesthesiology
Product Code
CAE
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
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
55
55
Inflation Problem
33
33
Deflation Problem
24
24
Break
18
18
Leak/Splash
17
17
Material Separation
17
17
Adverse Event Without Identified Device or Use Problem
10
10
Detachment of Device or Device Component
10
10
Deformation Due to Compressive Stress
8
8
Material Split, Cut or Torn
7
7
Physical Resistance/Sticking
6
6
Obstruction of Flow
6
6
Material Integrity Problem
6
6
Inadequacy of Device Shape and/or Size
6
6
Use of Device Problem
5
5
Device Damaged Prior to Use
5
5
Contamination /Decontamination Problem
5
5
Disconnection
5
5
Material Protrusion/Extrusion
5
5
Appropriate Term/Code Not Available
5
5
Material Deformation
4
4
Structural Problem
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Material Puncture/Hole
4
4
Fitting Problem
4
4
Device Handling Problem
3
3
Material Rupture
3
3
Difficult to Insert
3
3
Separation Problem
3
3
Device Dislodged or Dislocated
3
3
Insufficient Information
3
3
Loose or Intermittent Connection
3
3
Improper or Incorrect Procedure or Method
3
3
Nonstandard Device
3
3
Fracture
2
2
Complete Blockage
2
2
Positioning Problem
2
2
Defective Device
2
2
Unintended Movement
2
2
Patient Device Interaction Problem
2
2
Device Markings/Labelling Problem
2
2
Material Fragmentation
2
2
Material Too Rigid or Stiff
2
2
Infusion or Flow Problem
2
2
Delivered as Unsterile Product
2
2
Protective Measures Problem
1
1
Product Quality Problem
1
1
Pressure Problem
1
1
Incorrect Measurement
1
1
Difficult to Advance
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
156
156
No Consequences Or Impact To Patient
58
58
No Patient Involvement
24
24
Insufficient Information
24
24
No Known Impact Or Consequence To Patient
15
15
Foreign Body In Patient
6
6
Low Oxygen Saturation
5
5
Cardiac Arrest
3
3
Numbness
3
3
Hypoxia
3
3
Airway Obstruction
3
3
Unintended Extubation
3
3
Cyanosis
2
2
Death
2
2
Hypoventilation
2
2
No Code Available
2
2
Ecchymosis
2
2
Laceration(s)
2
2
Respiratory Insufficiency
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Respiratory Arrest
1
1
Unspecified Gastrointestinal Problem
1
1
Hematoma
1
1
Abrasion
1
1
Laceration(s) of Esophagus
1
1
Obstruction/Occlusion
1
1
Dysphagia/ Odynophagia
1
1
Pulmonary Edema
1
1
Bronchospasm
1
1
Unspecified Tissue Injury
1
1
Ulcer
1
1
Hemorrhage/Bleeding
1
1
Pressure Sores
1
1
Extubate
1
1
Respiratory Failure
1
1
Bruise/Contusion
1
1
Device Embedded In Tissue or Plaque
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
II
Sep-06-2024
5
MEDLINE INDUSTRIES, LP - Northfield
I
Feb-25-2024
6
MEDLINE INDUSTRIES, LP - Northfield
II
Jul-21-2023
7
MEDLINE INDUSTRIES, LP - Northfield
II
Apr-14-2022
8
Sarnova HC, Llc
II
Jan-12-2024
9
SunMed Holdings, LLC
II
Jan-26-2023
-
-