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TPLC
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show TPLC since
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Device
spirometer, therapeutic (incentive)
Product Code
BWF
Regulation Number
868.5690
Device Class
2
Premarket Reviews
Manufacturer
Decision
D R BURTON HEALTHCARE, LLC
SUBSTANTIALLY EQUIVALENT
1
ENCHANT TEK CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
LUNG TRAINERS, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PEEP MEDICAL LLC DBA GO2 DEVICES
SUBSTANTIALLY EQUIVALENT
1
RESPINOVA LTD.
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
TRUDELL MEDICAL INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
16
16
2020
5
5
2021
9
9
2022
8
8
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
12
12
Gas/Air Leak
5
5
Material Separation
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Leak/Splash
2
2
Break
2
2
Material Fragmentation
2
2
Packaging Problem
1
1
Partial Blockage
1
1
Labelling, Instructions for Use or Training Problem
1
1
Fracture
1
1
Failure to Cycle
1
1
Loose or Intermittent Connection
1
1
No Flow
1
1
Defective Component
1
1
Defective Device
1
1
Vibration
1
1
Component Missing
1
1
Particulates
1
1
Device Damaged Prior to Use
1
1
Device Markings/Labelling Problem
1
1
Crack
1
1
Contamination
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
17
17
No Consequences Or Impact To Patient
16
16
Insufficient Information
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Death
1
1
Sepsis
1
1
No Code Available
1
1
Cardiac Arrest
1
1
No Known Impact Or Consequence To Patient
1
1
Foreign Body In Patient
1
1
Numbness
1
1
Respiratory Tract Infection
1
1
No Patient Involvement
1
1
Bronchospasm
1
1
Cough
1
1
Low Oxygen Saturation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Smiths Medical ASD Inc.
II
Jan-15-2021
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