TPLC - Total Product Life Cycle

show TPLC since

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	3
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	274	274
Device Emits Odor	197	197
Use of Device Problem	60	60
Leak/Splash	29	29
Insufficient Information	20	20
Device Handling Problem	20	20
Smoking	17	17
Fire	15	15
Adverse Event Without Identified Device or Use Problem	13	13
Fluid/Blood Leak	7	7
Improper or Incorrect Procedure or Method	5	5
Pressure Problem	4	4
Material Integrity Problem	4	4
Gas/Air Leak	3	3
Appropriate Term/Code Not Available	3	3
Fumes or Vapors	2	2
Mechanical Problem	2	2
Device Damaged Prior to Use	2	2
Sparking	1	1
Output Problem	1	1
Crack	1	1
Therapeutic or Diagnostic Output Failure	1	1
Ejection Problem	1	1
Shipping Damage or Problem	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Failure to Calibrate	1	1
Device Reprocessing Problem	1	1
Failure to Cycle	1	1
Display or Visual Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	430	430
Burn(s)	76	76
Insufficient Information	28	28
No Consequences Or Impact To Patient	24	24
Skin Discoloration	19	19
Skin Burning Sensation	12	12
Headache	10	10
Burning Sensation	6	6
Superficial (First Degree) Burn	5	5
Itching Sensation	5	5
Eye Burn	4	4
Dyspnea	4	4
Pain	4	4
Unspecified Respiratory Problem	4	4
Red Eye(s)	3	3
Dizziness	3	3
Cough	3	3
Eye Pain	3	3
Skin Irritation	2	2
Bone Fracture(s)	2	2
Swelling/ Edema	2	2
Damage to Ligament(s)	1	1
Nausea	1	1
Skin Inflammation/ Irritation	1	1
Hematoma	1	1
Reaction to Medicinal Component of Device	1	1
Fever	1	1
Rash	1	1
Unspecified Eye / Vision Problem	1	1
Discomfort	1	1
Erythema	1	1
Laceration(s)	1	1
Pneumonia	1	1
Caustic/Chemical Burns	1	1
Blurred Vision	1	1
Sore Throat	1	1