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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device sterilizer, chemical
Product CodeMLR
Regulation Number 880.6860
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED STERILIZATION PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PLASMAPP CO,.LTD
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
STERILUCENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 222 222
2020 174 174
2021 202 202
2022 188 188
2023 140 140
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Environmental Particulates 416 416
Device Emits Odor 345 345
Smoking 69 69
Use of Device Problem 38 38
Adverse Event Without Identified Device or Use Problem 35 35
Fluid/Blood Leak 22 22
Device Handling Problem 19 19
Appropriate Term/Code Not Available 10 10
Insufficient Information 9 9
Fire 9 9
Leak/Splash 9 9
Improper or Incorrect Procedure or Method 8 8
Gas/Air Leak 7 7
Chemical Problem 6 6
Pressure Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
Fumes or Vapors 3 3
Patient-Device Incompatibility 3 3
Fogging 2 2
Break 2 2
Thermal Decomposition of Device 2 2
Failure to Cycle 2 2
Moisture or Humidity Problem 2 2
Material Discolored 1 1
Device Reprocessing Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Failure to Align 1 1
Expiration Date Error 1 1
Inadequate or Insufficient Training 1 1
Shipping Damage or Problem 1 1
Electrical Power Problem 1 1
Material Integrity Problem 1 1
Output Problem 1 1
No Apparent Adverse Event 1 1
Temperature Problem 1 1
Noise, Audible 1 1
Ejection Problem 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 402 402
No Consequences Or Impact To Patient 330 330
Burn(s) 35 35
Insufficient Information 27 27
Headache 26 26
Burn, Thermal 24 24
No Code Available 20 20
Skin Irritation 18 18
Burning Sensation 16 16
Irritation 12 12
Skin Discoloration 12 12
No Known Impact Or Consequence To Patient 11 11
Skin Burning Sensation 10 10
Itching Sensation 8 8
Nausea 8 8
Dizziness 6 6
Superficial (First Degree) Burn 5 5
Red Eye(s) 5 5
Dyspnea 4 4
Eye Burn 4 4
Caustic/Chemical Burns 4 4
Unspecified Respiratory Problem 3 3
Eye Pain 3 3
Cough 2 2
Injury 2 2
Sore Throat 1 1
Reaction 1 1
Chest Tightness/Pressure 1 1
Discomfort 1 1
Unspecified Eye / Vision Problem 1 1
Chemical Exposure 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Pain 1 1
Pneumonia 1 1
Rash 1 1
Damage to Ligament(s) 1 1
Swelling 1 1
Tachycardia 1 1
Blurred Vision 1 1
Skin Inflammation/ Irritation 1 1
Reaction to Medicinal Component of Device 1 1
Swelling/ Edema 1 1

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