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TPLC
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Device
sterilant, medical devices
Product Code
MED
Regulation Number
880.6885
Device Class
2
Premarket Reviews
Manufacturer
Decision
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
8
STERIS CORPORATIONS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
35
35
2020
32
32
2021
31
31
2022
16
16
2023
9
9
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Improper or Incorrect Procedure or Method
33
33
Use of Device Problem
19
19
Fluid/Blood Leak
18
18
Adverse Event Without Identified Device or Use Problem
14
14
Failure to Disinfect
11
11
Problem with Sterilization
9
9
Leak/Splash
8
8
Chemical Problem
5
5
Device Handling Problem
4
4
Break
4
4
Insufficient Information
3
3
Appropriate Term/Code Not Available
2
2
Defective Device
2
2
Patient-Device Incompatibility
2
2
Deformation Due to Compressive Stress
1
1
Insufficient Flow or Under Infusion
1
1
Inadequate or Insufficient Training
1
1
Material Fragmentation
1
1
Device Reprocessing Problem
1
1
Contamination
1
1
Fire
1
1
Device Emits Odor
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Too Rigid or Stiff
1
1
Shipping Damage or Problem
1
1
Failure to Clean Adequately
1
1
Device Markings/Labelling Problem
1
1
Difficult to Open or Close
1
1
Device Contamination with Chemical or Other Material
1
1
Power Problem
1
1
Unintended Movement
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
33
33
Burning Sensation
23
23
Skin Discoloration
16
16
No Known Impact Or Consequence To Patient
13
13
Chemical Exposure
9
9
Insufficient Information
7
7
Skin Irritation
6
6
Irritation
6
6
Anaphylactic Shock
5
5
Burn(s)
5
5
No Code Available
5
5
No Consequences Or Impact To Patient
5
5
Respiratory Tract Infection
4
4
Unspecified Infection
4
4
Nasal Obstruction
3
3
Skin Burning Sensation
3
3
Skin Inflammation/ Irritation
2
2
Swelling/ Edema
2
2
Sore Throat
2
2
Unspecified Eye / Vision Problem
2
2
Cough
2
2
Wheezing
2
2
Burn, Thermal
2
2
Caustic/Chemical Burns
2
2
Bronchospasm
2
2
Blurred Vision
2
2
Dyspnea
2
2
Headache
2
2
Low Blood Pressure/ Hypotension
2
2
Erythema
1
1
Corneal Abrasion
1
1
Asthma
1
1
Bruise/Contusion
1
1
Swelling
1
1
Itching Sensation
1
1
Nausea
1
1
Pain
1
1
Red Eye(s)
1
1
Decreased Sensitivity
1
1
Superficial (First Degree) Burn
1
1
Syncope/Fainting
1
1
Eye Burn
1
1
Dizziness
1
1
Excessive Tear Production
1
1
Discomfort
1
1
Injury
1
1
Unspecified Respiratory Problem
1
1
Eye Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
II
Jul-05-2019
2
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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