• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2018 289 289
2019 222 222
2020 174 174
2021 202 202
2022 188 188
2023 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Environmental Particulates 591 591
Device Emits Odor 407 407
Smoking 70 70
Adverse Event Without Identified Device or Use Problem 60 60
Use of Device Problem 29 29
Fluid/Blood Leak 23 23
Device Handling Problem 20 20
Appropriate Term/Code Not Available 17 17
Improper or Incorrect Procedure or Method 11 11
Chemical Problem 10 10
Fire 9 9
Leak/Splash 8 8
Gas/Air Leak 7 7
Insufficient Information 7 7
Patient-Device Incompatibility 5 5
Pressure Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Moisture or Humidity Problem 2 2
Chemical Spillage 2 2
Expiration Date Error 2 2
Fumes or Vapors 2 2
Fogging 2 2
Break 2 2
Thermal Decomposition of Device 2 2
Failure to Cycle 2 2
Degraded 2 2
Material Discolored 1 1
Device Reprocessing Problem 1 1
Mechanical Problem 1 1
Defective Component 1 1
Residue After Decontamination 1 1
Failure to Align 1 1
Overheating of Device 1 1
Increase in Pressure 1 1
Shipping Damage or Problem 1 1
Device Displays Incorrect Message 1 1
Inadequate or Insufficient Training 1 1
Device Operates Differently Than Expected 1 1
Electrical Power Problem 1 1
Temperature Problem 1 1
Output Problem 1 1
Material Integrity Problem 1 1
No Apparent Adverse Event 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 Consequences Or Impact To Patient 552 552
No Clinical Signs, Symptoms or Conditions 387 387
Burn, Thermal 49 49
Burning Sensation 31 31
Skin Irritation 28 28
Burn(s) 27 27
Headache 27 27
Insufficient Information 27 27
No Code Available 23 23
No Known Impact Or Consequence To Patient 18 18
Irritation 16 16
Itching Sensation 14 14
Skin Burning Sensation 10 10
Skin Discoloration 8 8
Nausea 7 7
Dizziness 6 6
Caustic/Chemical Burns 6 6
Superficial (First Degree) Burn 5 5
Eye Burn 4 4
Red Eye(s) 4 4
Dyspnea 4 4
Unspecified Respiratory Problem 3 3
Eye Pain 3 3
Cough 2 2
Chemical Exposure 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
Skin Inflammation/ Irritation 1 1
Reaction to Medicinal Component of Device 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Pneumonia 1 1
Rash 1 1
Swelling 1 1
Tachycardia 1 1
Blurred Vision 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Steris Corporation II Aug-31-2018
2 Steris Corporation II Feb-13-2018
-
-