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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mask, oxygen
Product CodeBYG
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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