TPLC - Total Product Life Cycle

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Device	hemostatic wound dressing without thrombin or other biologics
Definition	To temporarily control bleeding and cover external wounds.
Product Code	QSY
Device Class	Unclassified

Premarket Reviews
Manufacturer	Decision
ADVAMEDICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
BC3 TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
CRESILON, INC.
	SUBSTANTIALLY EQUIVALENT	3
HANGZHOU ZEO-INNOV LIFE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INCORE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU NEWVALUE MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KOAG, LLC
	SUBSTANTIALLY EQUIVALENT	1
MACHINA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRADE PRODUCTS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
STARCH MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
USHARE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4	4
Lack of Effect	3	3
Insufficient Information	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Off-Label Use	1	1
Material Fragmentation	1	3
Unraveled Material	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Airway Obstruction	4	6
No Clinical Signs, Symptoms or Conditions	3	3
Septic Shock	3	5
Hemorrhage/Bleeding	3	3
High Oxygen Saturation	2	2
Foreign Body In Patient	2	2
Insufficient Information	2	2
Glaucoma	1	1
Erythema	1	1
Visual Impairment	1	1
Partial Hearing Loss	1	1
Pneumonia	1	1
Nasal Obstruction	1	1
Shock	1	1
Unspecified Tissue Injury	1	1
Skin Tears	1	1
Tissue Breakdown	1	1