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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 1
BIONOVA MEDICAL, INC.
  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
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 2
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
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
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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 22 22
Patient Device Interaction Problem 13 13
Adverse Event Without Identified Device or Use Problem 10 10
Appropriate Term/Code Not Available 6 6
Off-Label Use 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Material Split, Cut or Torn 1 1
Material Integrity Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Shipping Damage or Problem 1 1
Material Too Rigid or Stiff 1 1
Labelling, Instructions for Use or Training Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Bacterial Infection 10 10
Unspecified Infection 8 8
Fluid Discharge 8 8
Swelling/ Edema 7 7
Insufficient Information 6 6
Purulent Discharge 5 5
Seroma 5 5
Skin Discoloration 5 5
Granuloma 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Peeling 4 4
Skin Inflammation/ Irritation 4 4
Ulcer 3 3
Wound Dehiscence 3 3
Tachycardia 3 3
Pain 3 3
Erythema 3 3
Fever 3 3
Cellulitis 3 3
Urinary Tract Infection 2 2
Tissue Breakdown 2 2
Cough 2 2
Discomfort 2 2
Chills 2 2
Hematoma 2 2
Dizziness 2 2
Sepsis 2 2
Fatigue 2 2
Failure of Implant 2 2
Hypersensitivity/Allergic reaction 2 2
Skin Infection 2 2
Post Operative Wound Infection 1 1
Post Traumatic Wound Infection 1 1
Injury 1 1
Rash 1 1
Unspecified Nervous System Problem 1 1
Itching Sensation 1 1
Embolism/Embolus 1 1
Osteomyelitis 1 1
Skin Erosion 1 1
Necrosis 1 1
Visual Impairment 1 1
Abscess 1 1
Unspecified Gastrointestinal Problem 1 1
Fungal Infection 1 1
Drug Resistant Bacterial Infection 1 1
Unspecified Heart Problem 1 1
No Consequences Or Impact To Patient 1 1
Impaired Healing 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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