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
ACELL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ACRO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AROA BIOSURGERY LTD.
	SUBSTANTIALLY EQUIVALENT	2
COLLAGEN MATRIX, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONVATEC TRIAD LIFE SCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
FESARIUSTHERAPEUTICS 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
SMITH & NEPHEW MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
STIMLABS, LLC
	SUBSTANTIALLY EQUIVALENT	2
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	13	13
Appropriate Term/Code Not Available	8	8
Patient Device Interaction Problem	7	7
Off-Label Use	6	6
Use of Device Problem	6	6
Improper or Incorrect Procedure or Method	6	6
Shipping Damage or Problem	2	2
Labelling, Instructions for Use or Training Problem	2	2
Material Integrity Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Material Too Rigid or Stiff	1	1
Tear, Rip or Hole in Device Packaging	1	1
Contamination of Device Ingredient or Reagent	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12	12
Bacterial Infection	11	11
Fluid Discharge	8	8
Swelling/ Edema	7	7
Unspecified Infection	6	6
Purulent Discharge	5	5
Skin Discoloration	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Peeling	4	4
Skin Inflammation/ Irritation	4	4
Injury	4	4
No Known Impact Or Consequence To Patient	4	4
Granuloma	3	3
Wound Dehiscence	3	3
Ulcer	3	3
Tachycardia	3	3
No Code Available	3	3
Pain	3	3
Insufficient Information	3	3
Erythema	3	3
Cellulitis	3	3
Fever	3	3
Urinary Tract Infection	2	2
Tissue Breakdown	2	2
Cough	2	2
Discomfort	2	2
Chills	2	2
Dizziness	2	2
Necrosis	2	2
Sepsis	2	2
Failure of Implant	2	2
Fatigue	2	2
Hypersensitivity/Allergic reaction	2	2
Skin Infection	2	2
Unspecified Nervous System Problem	1	1
Rash	1	1
Seroma	1	1
Skin Erosion	1	1
Ossification	1	1
Itching Sensation	1	1
Osteomyelitis	1	1
Embolism/Embolus	1	1
Swelling	1	1
Hematoma	1	1
Unspecified Gastrointestinal Problem	1	1
Visual Impairment	1	1
Abscess	1	1
Fungal Infection	1	1
Drug Resistant Bacterial Infection	1	1
Unspecified Heart Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Collagen Matrix Inc	II	Sep-23-2022
2	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
3	ProgenaCare	II	May-26-2022
4	Southwest Technologies Inc	II	Jul-21-2021
5	TEI Biosciences, Inc.	II	Sep-30-2024