TPLC - Total Product Life Cycle

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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

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
Failure to Cycle	2	2
Moisture or Humidity Problem	2	2
Thermal Decomposition of Device	2	2
Fogging	2	2
Break	2	2
Material Discolored	1	1
Failure to Align	1	1
Shipping Damage or Problem	1	1
Ejection Problem	1	1
Material Integrity Problem	1	1
Expiration Date Error	1	1
Defective Component	1	1
Electrical Power Problem	1	1
No Apparent Adverse Event	1	1
Failure to Calibrate	1	1
Device Damaged Prior to Use	1	1
Excessive Heating	1	1
Output Problem	1	1
Device Reprocessing Problem	1	1
Inadequate or Insufficient Training	1	1
Sparking	1	1
Temperature Problem	1	1
Noise, Audible	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
Eye Burn	4	4
Caustic/Chemical Burns	4	4
Dyspnea	4	4
Eye Pain	3	3
Swelling/ Edema	2	2
Cough	2	2
Pain	2	2
Injury	2	2
Rash	1	1
Erythema	1	1
Swelling	1	1
Discomfort	1	1
Unspecified Eye / Vision Problem	1	1
Fever	1	1
Pneumonia	1	1
Reaction	1	1
Reaction to Medicinal Component of Device	1	1
Chemical Exposure	1	1
Tachycardia	1	1
Chest Tightness/Pressure	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