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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wound dressing with animal-derived material(s)
Product CodeKGN
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ACELL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ACRO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ADVAMEDICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
AROA BIOSURGERY , LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIONOVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOTISSUE HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONVATEC TRIAD LIFE SCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ECM THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FESARIUSTHERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FETTECH
  SUBSTANTIALLY EQUIVALENT 1
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 3
GENIPHYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUNZE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
HELIOS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HUMAN BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KERECIS LIMITED
  SUBSTANTIALLY EQUIVALENT 3
LACERTA LIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
LACERTA LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
MAXIGEN BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDSKIN SOLUTIONS DR. SUWELACK AG
  SUBSTANTIALLY EQUIVALENT 3
NEXTGEN BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVABONE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORGANOGENESIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OVIGENEX, LLC
  SUBSTANTIALLY EQUIVALENT 2
REPRISE BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
REPRISE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
ROOSIN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STIMLABS, LLC
  SUBSTANTIALLY EQUIVALENT 3
STRUKMYER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
TRIAD LIFE SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 3
VENTRIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WINNER MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 14 14
2022 13 13
2023 21 21
2024 15 15
2025 15 15
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Device Problem Information 22 22
Adverse Event Without Identified Device or Use Problem 13 13
Patient Device Interaction Problem 13 13
Appropriate Device Problem Term/Code Not Available 6 6
Off-Label Use 2 2
Contamination 2 2
Improper or Incorrect Procedure or Method 2 2
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Contamination of Device Ingredient or Reagent 1 1
Use of Device Problem 1 1
Device Damaged Prior to Receipt by User 1 1
Material Integrity Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Material Too Rigid or Stiff 1 1
Material Split, Cut or Torn 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
Bacterial Infection 12 12
Unspecified Infection 9 9
Fluid Discharge 8 8
Swelling/ Edema 7 7
Insufficient Information 6 6
Skin Discoloration 5 5
Seroma 5 5
Purulent Discharge 5 5
Peeling 4 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Granuloma 4 4
Skin Inflammation/ Irritation 4 4
Cellulitis 3 3
Erythema 3 3
Tachycardia 3 3
Pain 3 3
Ulcer 3 3
Fever 3 3
Wound Dehiscence 3 3
Chills 2 2
Hematoma 2 2
Impaired Healing 2 2
Dizziness 2 2
Skin Infection 2 2
Urinary Tract Infection 2 2
Cough 2 2
Discomfort 2 2
Osteomyelitis 2 2
Hypersensitivity/Allergic reaction 2 2
Post Operative Wound Infection 2 2
Sepsis 2 2
Tissue Breakdown 2 2
Fatigue 2 2
Failure of Implant 2 2
Abscess 1 1
Visual Impairment 1 1
Weight Changes 1 1
Drug Resistant Bacterial Infection 1 1
Injury 1 1
Embolism/Embolus 1 1
Skin Erosion 1 1
No Consequences Or Impact To Patient 1 1
High Blood Pressure/ Hypertension 1 1
Nervous System Injury 1 1
Unspecified Nervous System Problem 1 1
Wound Infection 1 1
Unspecified Heart Problem 1 1
Rash 1 1
Necrosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Collagen Matrix Inc II Sep-23-2022
2 Integra LifeSciences Corp. (NeuroSciences) II Apr-15-2026
3 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
4 Medline Industries, LP II Mar-27-2026
5 ProgenaCare II May-26-2022
6 Southwest Technologies Inc II Jul-21-2021
7 TEI Biosciences, Inc. II Sep-30-2024
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