TPLC - Total Product Life Cycle

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Device	sterilizer, chemical
Regulation Description	Ethylene oxide gas sterilizer.
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	4
IDEATE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
LOWTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PLASMAPP CO,., LTD.
	SUBSTANTIALLY EQUIVALENT	4
STERIS
	SUBSTANTIALLY EQUIVALENT	2
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Environmental Particulates	275	275
Device Emits Odor	184	184
Use of Device Problem	63	63
Leak/Splash	37	37
Insufficient Device Problem Information	22	22
Device Handling Problem	20	20
Fire	12	12
Adverse Event Without Identified Device or Use Problem	11	11
Smoking	5	5
Fluid/Blood Leak	3	3
Improper or Incorrect Procedure or Method	3	3
Material Integrity Problem	3	3
Device Damaged Prior to Use	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Mechanical Problem	2	2
Device Damaged Prior to Receipt by User	2	2
Gas/Air Leak	2	2
Detachment of Device or Device Component	1	1
Failure to Calibrate	1	1
Pressure Problem	1	1
Sparking	1	1
Display or Visual Feedback Problem	1	1
Fumes or Vapors	1	1
No Apparent Adverse Event	1	1
Ejection Problem	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	432	432
Burn(s)	88	88
Insufficient Information	28	28
No Consequences Or Impact To Patient	24	24
Skin Discoloration	19	19
Skin Burning Sensation	12	12
Headache	11	11
Eye Irritation	7	7
Dyspnea	7	7
Burning Sensation	6	6
Itching Sensation	5	5
Superficial (First Degree) Burn	5	5
Cough	5	5
Unspecified Respiratory Problem	5	5
Pain	4	4
Eye Burn	4	4
Dizziness	4	4
Eye Pain	3	3
Red Eye(s)	3	3
Skin Inflammation/ Irritation	2	2
Upper Respiratory Tract Irritation	2	2
Skin Irritation	2	2
Bone Fracture(s)	2	2
Swelling/ Edema	2	2
Unspecified Eye / Vision Problem	1	1
Discomfort	1	1
Reaction to Medicinal Component of Device	1	1
Hematoma	1	1
Laceration(s)	1	1
Erythema	1	1
Nausea	1	1
Damage to Ligament(s)	1	1
Caustic/Chemical Burns	1	1
Chest Pain	1	1
Chemical Exposure	1	1
Blurred Vision	1	1
Sore Throat	1	1
Fever	1	1
Pneumonia	1	1
Rash	1	1