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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
mask, oxygen
Product Code
BYG
Regulation Number
868.5580
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
50
50
2015
63
63
2016
22
22
2017
8
8
2018
39
39
2019
29
29
2020
6
6
2021
12
12
2022
18
18
2023
4
4
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
59
59
Disconnection
34
34
Detachment Of Device Component
20
20
Inflation Problem
17
17
Connection Problem
14
14
Break
7
7
Obstruction of Flow
6
6
Material Integrity Problem
6
6
Nonstandard Device
6
6
Material Deformation
5
5
Occlusion Within Device
5
5
Insufficient Information
5
5
Loose or Intermittent Connection
5
5
Decoupling
4
4
Kinked
4
4
No Flow
4
4
Material Split, Cut or Torn
4
4
Fitting Problem
4
4
Leak/Splash
4
4
Defective Component
3
3
Incorrect Device Or Component Shipped
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Material Separation
3
3
Partial Blockage
3
3
Device Issue
2
2
Device Markings/Labelling Problem
2
2
Material Puncture/Hole
2
2
Patient-Device Incompatibility
2
2
Component Falling
2
2
Fluid/Blood Leak
2
2
Contamination /Decontamination Problem
2
2
Device Dislodged or Dislocated
2
2
Patient Device Interaction Problem
2
2
Air Leak
2
2
Hole In Material
2
2
Fracture
2
2
Material Twisted/Bent
2
2
Device Contamination with Chemical or Other Material
2
2
Infusion or Flow Problem
2
2
Misconnection
2
2
Failure to Unfold or Unwrap
2
2
Failure to Seal
2
2
Display or Visual Feedback Problem
1
1
Difficult to Open or Close
1
1
Material Too Soft/Flexible
1
1
Failure to Disconnect
1
1
Loss of or Failure to Bond
1
1
Appropriate Term/Code Not Available
1
1
Device Operates Differently Than Expected
1
1
Failure to Calibrate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
95
95
No Known Impact Or Consequence To Patient
66
66
No Patient Involvement
31
31
No Clinical Signs, Symptoms or Conditions
23
23
Low Oxygen Saturation
13
13
Tissue Breakdown
4
4
No Information
4
4
Insufficient Information
4
4
Corneal Abrasion
3
3
Death
2
2
Complaint, Ill-Defined
2
2
Respiratory Insufficiency
2
2
Skin Inflammation/ Irritation
2
2
Burn(s)
2
2
Hypoxia
2
2
Injury
2
2
Foreign Body In Patient
2
2
Dyspnea
2
2
Lethargy
1
1
Full thickness (Third Degree) Burn
1
1
Airway Obstruction
1
1
Loss of consciousness
1
1
Hemorrhage/Bleeding
1
1
Nasal Obstruction
1
1
Reaction
1
1
Choking
1
1
Discomfort
1
1
Swelling
1
1
Erythema
1
1
Conjunctivitis
1
1
Visual Disturbances
1
1
Skin Erosion
1
1
Rash
1
1
Confusion/ Disorientation
1
1
Blister
1
1
Abnormal Blood Gases
1
1
No Code Available
1
1
Respiratory Distress
1
1
Unspecified Infection
1
1
Foreign Body Sensation in Eye
1
1
Cyanosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ConvaTec, Inc
II
May-24-2017
2
Convatec Inc.
II
Feb-15-2011
3
Intersurgical Inc
II
Dec-07-2017
4
King Systems Corp.
II
Apr-06-2011
5
POM Medical LLC
II
Oct-31-2019
6
Salter Laboratories, Division of Regulatory Affairs
II
Oct-26-2011
7
Salter Labs
II
Jul-23-2014
8
Smiths Medical
II
Jun-24-2011
9
Vital Signs Devices, a GE Healthcare Company
II
Jun-29-2011
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