TPLC - Total Product Life Cycle

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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

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	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
Insufficient Information	9	9
Fire	9	9
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
Therapeutic or Diagnostic Output Failure	3	3
Fumes or Vapors	3	3
Patient-Device Incompatibility	3	3
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
Device Damaged Prior to Use	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	402	402
No Consequences Or Impact To Patient	330	330
Burn(s)	34	34
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	12	12
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