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TPLC
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show TPLC since
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Device
sterilizer, chemical
Product Code
MLR
Regulation Number
880.6860
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED STERILIZATION PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
ADVANCED STERILIZATION PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
2
IDEATE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
LOWTEM CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
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
27
27
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
47
47
Adverse Event Without Identified Device or Use Problem
37
37
Fluid/Blood Leak
22
22
Device Handling Problem
21
21
Insufficient Information
12
12
Fire
10
10
Appropriate Term/Code Not Available
10
10
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
Fumes or Vapors
3
3
Patient-Device Incompatibility
3
3
Therapeutic or Diagnostic Output Failure
3
3
Thermal Decomposition of Device
2
2
Moisture or Humidity Problem
2
2
Fogging
2
2
Failure to Cycle
2
2
Break
2
2
Inadequate or Insufficient Training
1
1
Device Reprocessing Problem
1
1
Noise, Audible
1
1
Temperature Problem
1
1
Failure to Calibrate
1
1
Excessive Heating
1
1
Defective Component
1
1
Expiration Date Error
1
1
Material Integrity Problem
1
1
Failure to Align
1
1
No Apparent Adverse Event
1
1
Ejection Problem
1
1
Material Discolored
1
1
Device Damaged Prior to Use
1
1
Electrical Power Problem
1
1
Shipping Damage or Problem
1
1
Output Problem
1
1
Sparking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
404
404
No Consequences Or Impact To Patient
330
330
Burn(s)
44
44
Headache
27
27
Insufficient Information
27
27
Burn, Thermal
24
24
No Code Available
20
20
Skin Irritation
18
18
Skin Discoloration
17
17
Burning Sensation
16
16
Skin Burning Sensation
12
12
Irritation
12
12
No Known Impact Or Consequence To Patient
11
11
Nausea
8
8
Itching Sensation
8
8
Dizziness
6
6
Superficial (First Degree) Burn
5
5
Red Eye(s)
5
5
Unspecified Respiratory Problem
4
4
Caustic/Chemical Burns
4
4
Dyspnea
4
4
Eye Burn
4
4
Eye Pain
3
3
Injury
2
2
Pain
2
2
Cough
2
2
Swelling/ Edema
2
2
Reaction to Medicinal Component of Device
1
1
Fever
1
1
Rash
1
1
Swelling
1
1
Chest Tightness/Pressure
1
1
Unspecified Eye / Vision Problem
1
1
Discomfort
1
1
Erythema
1
1
Chemical Exposure
1
1
Reaction
1
1
Pneumonia
1
1
Tachycardia
1
1
Hematoma
1
1
Blurred Vision
1
1
Bone Fracture(s)
1
1
Skin Inflammation/ Irritation
1
1
Damage to Ligament(s)
1
1
Sore Throat
1
1
High Blood Pressure/ Hypertension
1
1
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