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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cleaner, ultrasonic, medical instrument
Product CodeFLG
Regulation Number 880.6150
Device Class 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 1 1
2022 12 12
2023 9 9
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Use of Device Problem 4 4
Improper Chemical Reaction 4 4
Leak/Splash 3 3
Insufficient Information 3 3
Fire 2 2
Problem with Removal of Enzymatic Cleaner 2 2
Contamination /Decontamination Problem 2 2
Product Quality Problem 2 2
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Patient Device Interaction Problem 1 1
Obstruction of Flow 1 1
Device Difficult to Maintain 1 1
Lack of Effect 1 1
Device Reprocessing Problem 1 1
Failure of Device to Self-Test 1 1
False Positive Result 1 1
Improper or Incorrect Procedure or Method 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Corneal Edema 7 7
Insufficient Information 6 6
Rash 3 3
Headache 3 3
Electric Shock 1 1
Skin Inflammation/ Irritation 1 1
No Known Impact Or Consequence To Patient 1 1
Burning Sensation 1 1
Swelling/ Edema 1 1
Cough 1 1
Eye Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Steris Corporation II Jan-11-2021
2 Steris Corporation II Jul-24-2020
3 Young Dental Manufacturing I, LLC II Oct-01-2024
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