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TPLC
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show TPLC since
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2024
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Device
cleaner, ultrasonic, medical instrument
Product Code
FLG
Regulation Number
880.6150
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
7
7
2020
4
4
2021
1
1
2022
12
12
2023
9
9
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
7
7
Leak/Splash
4
4
Improper Chemical Reaction
4
4
Use of Device Problem
3
3
Insufficient Information
3
3
Appropriate Term/Code Not Available
2
2
Unintended Electrical Shock
2
2
Contamination /Decontamination Problem
2
2
Product Quality Problem
2
2
Problem with Removal of Enzymatic Cleaner
2
2
Fire
2
2
Device Reprocessing Problem
1
1
False Positive Result
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Misassembled
1
1
Failure of Device to Self-Test
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Obstruction of Flow
1
1
Patient-Device Incompatibility
1
1
Lack of Effect
1
1
Patient Device Interaction Problem
1
1
Output below Specifications
1
1
Device Difficult to Maintain
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Corneal Edema
7
7
No Clinical Signs, Symptoms or Conditions
7
7
Insufficient Information
5
5
No Consequences Or Impact To Patient
4
4
Electric Shock
3
3
Headache
2
2
No Information
2
2
Cough
1
1
Eye Pain
1
1
Skin Inflammation/ Irritation
1
1
Swelling/ Edema
1
1
Irritation
1
1
Rash
1
1
Burning Sensation
1
1
No Known Impact Or Consequence To Patient
1
1
Needle Stick/Puncture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Steris Corporation
II
Jan-11-2021
2
Steris Corporation
II
Jul-24-2020
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