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TPLC
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show TPLC since
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2024
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Device
sterilizer, chemical
Product Code
MLR
Regulation Number
880.6860
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Environmental Particulates
416
416
Device Emits Odor
344
344
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
18
18
Appropriate Term/Code Not Available
10
10
Fire
9
9
Leak/Splash
9
9
Improper or Incorrect Procedure or Method
8
8
Insufficient Information
8
8
Gas/Air Leak
7
7
Chemical Problem
6
6
Pressure Problem
4
4
Therapeutic or Diagnostic Output Failure
3
3
Patient-Device Incompatibility
3
3
Fumes or Vapors
2
2
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
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
401
401
No Consequences Or Impact To Patient
330
330
Burn(s)
33
33
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
11
11
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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