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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 4
ACRO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AROA BIOSURGERY , LTD.
  SUBSTANTIALLY EQUIVALENT 2
CELL CONSTRUCTS I, LLC
  SUBSTANTIALLY EQUIVALENT 1
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
GENIPHYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUNZE LIMITED
  SUBSTANTIALLY EQUIVALENT 3
HELIOS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
HUMAN BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFE SCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KERANETICS
  SUBSTANTIALLY EQUIVALENT 1
KERECIS LIMITED
  SUBSTANTIALLY EQUIVALENT 4
MAXIGEN BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
OVIGENEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 2

MDR Year MDR Reports MDR Events
2019 11 12
2020 17 17
2021 14 14
2022 13 13
2023 21 21
2024 15 15
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 23 23
Adverse Event Without Identified Device or Use Problem 15 15
Use of Device Problem 14 14
Off-Label Use 13 13
Patient Device Interaction Problem 13 13
Improper or Incorrect Procedure or Method 13 13
Appropriate Term/Code Not Available 8 8
Shipping Damage or Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Unsealed Device Packaging 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 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
Delivered as Unsterile Product 1 2
Tear, Rip or Hole in Device Packaging 1 1
Contamination of Device Ingredient or Reagent 1 1
Nonstandard Device 1 2
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 15 16
No Clinical Signs, Symptoms or Conditions 14 14
Bacterial Infection 12 12
Fluid Discharge 8 8
Swelling/ Edema 7 7
Insufficient Information 5 5
Purulent Discharge 5 5
Seroma 5 5
Skin Discoloration 5 5
Fever 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 4 4
Peeling 4 4
Skin Inflammation/ Irritation 4 4
Swelling 4 4
Itching Sensation 4 4
No Known Impact Or Consequence To Patient 4 4
Injury 4 4
Rash 4 4
Granuloma 3 3
Ulcer 3 3
Wound Dehiscence 3 3
Tachycardia 3 3
Pain 3 3
Erythema 3 3
Cellulitis 3 3
Urinary Tract Infection 2 2
Tissue Breakdown 2 2
Cough 2 2
Discomfort 2 2
Chest Pain 2 2
Chills 2 2
Hematoma 2 2
Dizziness 2 2
Necrosis 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
Unspecified Nervous System Problem 1 1
Ossification 1 1
Embolism/Embolus 1 1
Osteomyelitis 1 1
Skin Erosion 1 1
Disability 1 1
Visual Impairment 1 1
Abscess 1 1
Unspecified Gastrointestinal Problem 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
7 TEI Biosciences, Inc. II Sep-30-2024
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