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
STERIS
	SUBSTANTIALLY EQUIVALENT	2
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Environmental Particulates	305	305
Device Emits Odor	255	255
Smoking	69	69
Use of Device Problem	51	51
Device Handling Problem	20	20
Fluid/Blood Leak	18	18
Leak/Splash	14	14
Insufficient Information	14	14
Adverse Event Without Identified Device or Use Problem	14	14
Fire	8	8
Improper or Incorrect Procedure or Method	8	8
Gas/Air Leak	7	7
Appropriate Term/Code Not Available	6	6
Pressure Problem	4	4
Chemical Problem	3	3
Patient-Device Incompatibility	3	3
Therapeutic or Diagnostic Output Failure	3	3
Fumes or Vapors	2	2
Device Damaged Prior to Use	2	2
Fogging	2	2
Thermal Decomposition of Device	2	2
Sparking	1	1
Output Problem	1	1
Defective Component	1	1
Expiration Date Error	1	1
Material Integrity Problem	1	1
Ejection Problem	1	1
Shipping Damage or Problem	1	1
Failure to Align	1	1
Moisture or Humidity Problem	1	1
No Apparent Adverse Event	1	1
Failure to Calibrate	1	1
Excessive Heating	1	1
Device Reprocessing Problem	1	1
Failure to Cycle	1	1
Inadequate or Insufficient Training	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	406	406
No Consequences Or Impact To Patient	169	169
Burn(s)	55	55
Insufficient Information	27	27
Skin Discoloration	18	18
Skin Irritation	14	14
Headache	13	13
Skin Burning Sensation	12	12
Burning Sensation	9	9
Superficial (First Degree) Burn	5	5
Itching Sensation	5	5
Dizziness	4	4
Burn, Thermal	4	4
Unspecified Respiratory Problem	4	4
Eye Burn	4	4
Dyspnea	4	4
No Code Available	3	3
Nausea	3	3
Red Eye(s)	3	3
Eye Pain	3	3
Irritation	3	3
Caustic/Chemical Burns	3	3
Pain	3	3
No Known Impact Or Consequence To Patient	2	2
Injury	2	2
Swelling/ Edema	2	2
Cough	2	2
Sore Throat	1	1
Blurred Vision	1	1
Tachycardia	1	1
Pneumonia	1	1
Reaction	1	1
Erythema	1	1
Discomfort	1	1
Unspecified Eye / Vision Problem	1	1
Swelling	1	1
Rash	1	1
Fever	1	1
Reaction to Medicinal Component of Device	1	1
Hematoma	1	1
Bone Fracture(s)	1	1
Skin Inflammation/ Irritation	1	1
Damage to Ligament(s)	1	1
High Blood Pressure/ Hypertension	1	1