TPLC - Total Product Life Cycle

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Device	absorbable synthetic wound dressing
Definition	Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Product Code	QSZ
Device Class	Unclassified

Premarket Reviews
Manufacturer	Decision
ACERA SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING KREATE MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
POLYNOVO BIOMATERIALS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	3
SIOXMED, LLC
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	47	47
Improper or Incorrect Procedure or Method	14	14
Adverse Event Without Identified Device or Use Problem	11	11
Use of Device Problem	2	2
Off-Label Use	1	1
Material Erosion	1	1
Material Fragmentation	1	1
Material Discolored	1	1
Device Handling Problem	1	1
Device Emits Odor	1	1
Tear, Rip or Hole in Device Packaging	1	1
No Apparent Adverse Event	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	35
Failure of Implant	6	6
Impaired Healing	4	4
Hematoma	4	4
Scar Tissue	4	4
Loss of Range of Motion	3	3
No Clinical Signs, Symptoms or Conditions	2	2
Purulent Discharge	2	2
Insufficient Information	2	2
Pain	2	2
Bacterial Infection	2	2
Unspecified Infection	1	1
Necrosis	1	1
Inflammation	1	1
Adhesion(s)	1	1
Skin Disorders	1	1
Rupture	1	1
Erythema	1	1
Fluid Discharge	1	1
Unspecified Tissue Injury	1	1
Perforation of Vessels	1	1
Hemorrhage/Bleeding	1	1
Granuloma	1	1