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
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
Appropriate Term/Code Not Available	10	10
Fire	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
Therapeutic or Diagnostic Output Failure	3	3
Patient-Device Incompatibility	3	3
Fogging	2	2
Thermal Decomposition of Device	2	2
Moisture or Humidity Problem	2	2
Failure to Cycle	2	2
Break	2	2
No Apparent Adverse Event	1	1
Expiration Date Error	1	1
Defective Component	1	1
Material Integrity Problem	1	1
Temperature Problem	1	1
Noise, Audible	1	1
Failure to Align	1	1
Material Discolored	1	1
Ejection Problem	1	1
Device Damaged Prior to Use	1	1
Electrical Power Problem	1	1
Output Problem	1	1
Sparking	1	1
Device Reprocessing Problem	1	1
Inadequate or Insufficient Training	1	1
Failure to Calibrate	1	1
Excessive Heating	1	1
Shipping Damage or Problem	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
Caustic/Chemical Burns	4	4
Dyspnea	4	4
Eye Burn	4	4
Eye Pain	3	3
Injury	2	2
Pain	2	2
Cough	2	2
Swelling/ Edema	2	2
Reaction to Medicinal Component of Device	1	1
Fever	1	1
Rash	1	1
Swelling	1	1
Chest Tightness/Pressure	1	1
Unspecified Eye / Vision Problem	1	1
Discomfort	1	1
Erythema	1	1
Chemical Exposure	1	1
Reaction	1	1
Pneumonia	1	1
Tachycardia	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