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TPLC
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show TPLC since
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Device
sterilizer, ethylene-oxide gas
Product Code
FLF
Regulation Number
880.6860
Device Class
2
Premarket Reviews
Manufacturer
Decision
3M COMPANY
SUBSTANTIALLY EQUIVALENT
1
ANDERSEN STERILIZERS, INC.
SUBSTANTIALLY EQUIVALENT
3
TSO3 INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
3
3
2016
3
3
2017
3
3
2019
2
2
2021
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Displays Incorrect Message
5
5
Leak/Splash
2
2
No Apparent Adverse Event
2
2
Device Sensing Problem
2
2
Appropriate Term/Code Not Available
2
2
Device Operates Differently Than Expected
2
2
Electrical /Electronic Property Problem
2
2
Failure to Sense
2
2
Gas/Air Leak
2
2
Overheating of Device
2
2
Temperature Problem
2
2
Break
1
1
Device Alarm System
1
1
Insufficient Information
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Device Emits Odor
1
1
Failure to Cycle
1
1
Improper Chemical Reaction
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Headache
9
9
Chemical Exposure
6
6
No Known Impact Or Consequence To Patient
5
5
Dizziness
3
3
Itching Sensation
2
2
No Consequences Or Impact To Patient
2
2
Respiratory Distress
1
1
Not Applicable
1
1
Burn(s)
1
1
Irritation
1
1
Burning Sensation
1
1
Vomiting
1
1
Dyspnea
1
1
Sore Throat
1
1
Eye Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Apr-24-2016
2
3M Company - Health Care Business
II
Apr-02-2014
3
3M Company - Health Care Business
II
Oct-09-2012
4
Advanced Sterilization Products
II
Dec-22-2014
5
Advanced Sterilization Products
II
Jan-14-2014
6
Advanced Sterilization Products
II
Jun-15-2009
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