TPLC - Total Product Life Cycle

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Device	wound dressing with animal-derived material(s)
Product Code	KGN
Device Class	Unclassified

Premarket Reviews
Manufacturer	Decision
ACELL, INC.
	SUBSTANTIALLY EQUIVALENT	2
AROA BIOSURGERY LTD.
	SUBSTANTIALLY EQUIVALENT	2
CELL CONSTRUCTS I, LLC
	SUBSTANTIALLY EQUIVALENT	1
COLLAGEN MATRIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
FETTECH
	SUBSTANTIALLY EQUIVALENT	1
FREUDENBERG TECHNOLOGY INNOVATION SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
GEISTLICH PHARMA AG
	SUBSTANTIALLY EQUIVALENT	1
GUNZE LIMITED
	SUBSTANTIALLY EQUIVALENT	3
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HUMAN BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KERANETICS
	SUBSTANTIALLY EQUIVALENT	1
KERECIS LIMITED
	SUBSTANTIALLY EQUIVALENT	2
MAXIGEN BIOTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDSKIN SOLUTIONS DR. SUWELACK AG
	SUBSTANTIALLY EQUIVALENT	1
NEXTGEN BIOLOGICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOVABONE PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORGANOGENESIS INC.
	SUBSTANTIALLY EQUIVALENT	2
REPRISE BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
REPRISE BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
STIMLABS, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRUKMYER MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
TRIAD LIFE SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	4
WINNER MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	18	18
Adverse Event Without Identified Device or Use Problem	14	14
Use of Device Problem	13	13
Improper or Incorrect Procedure or Method	13	13
Off-Label Use	13	13
Appropriate Term/Code Not Available	8	8
Patient Device Interaction Problem	7	7
Shipping Damage or Problem	2	2
Labelling, Instructions for Use or Training Problem	2	2
Inadequate Instructions for Healthcare Professional	1	1
Nonstandard Device	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1
Unexpected Therapeutic Results	1	1
Material Too Rigid or Stiff	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Bacterial Infection	12	12
No Clinical Signs, Symptoms or Conditions	9	9
Fluid Discharge	8	8
Unspecified Infection	8	8
Swelling/ Edema	7	7
Purulent Discharge	5	5
Fever	5	5
Skin Discoloration	5	5
Swelling	4	4
Injury	4	4
Itching Sensation	4	4
Peeling	4	4
Rash	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Skin Inflammation/ Irritation	4	4
No Known Impact Or Consequence To Patient	4	4
No Code Available	4	4
Insufficient Information	3	3
Granuloma	3	3
Erythema	3	3
Cellulitis	3	3
Wound Dehiscence	3	3
Ulcer	3	3
Tachycardia	3	3
Pain	3	3
Failure of Implant	2	2
Urinary Tract Infection	2	2
Chills	2	2
Dizziness	2	2
Chest Pain	2	2
Fatigue	2	2
Sepsis	2	2
Necrosis	2	2
Hypersensitivity/Allergic reaction	2	2
Skin Infection	2	2
Cough	2	2
Discomfort	2	2
Tissue Breakdown	2	2
Patient Problem/Medical Problem	1	1
Nervous System Injury	1	1
Unspecified Nervous System Problem	1	1
Embolism/Embolus	1	1
Unspecified Heart Problem	1	1
Unspecified Gastrointestinal Problem	1	1
Osteomyelitis	1	1
Drug Resistant Bacterial Infection	1	1
High Blood Pressure/ Hypertension	1	1
Seroma	1	1
Hematoma	1	1
Ossification	1	1
Abscess	1	1
No Consequences Or Impact To Patient	1	1
Pressure Sores	1	1
Disability	1	1
Fungal Infection	1	1
Weight Changes	1	1
Visual Impairment	1	1
Skin Erosion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Collagen Matrix Inc	II	Sep-23-2022
2	Integra Limited	II	May-15-2019
3	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
4	Molnlycke Health Care, Inc	II	Apr-30-2019
5	ProgenaCare	II	May-26-2022
6	Southwest Technologies Inc	II	Jul-21-2021