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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dressing, wound, drug
Product CodeFRO
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
3-D MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
3M HEALTHCARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 1
ADVAMEDICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED MEDICAL SOLUTIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL SOLUTIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ALLMED MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AMSINO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARCH THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGENTUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGENTUM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ATTWILL MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
BC3 TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIONOVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP.
  SUBSTANTIALLY EQUIVALENT 1
CRESILON, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENZYSURGE , LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN UNITED MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GEL4MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ZEO-INNOV LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HARTMANN USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD.
  SUBSTANTIALLY EQUIVALENT 10
IMBED BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 1
INFECTION ELIMINATION SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOVACYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRRIMAX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU EXCELLENCE MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU NEWVALUE MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JINHUA JINGDI MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KANE BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
KERICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOAG, LLC
  SUBSTANTIALLY EQUIVALENT 1
LABORATORIOS BIOGALENIC S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
MEBO LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMEZA, LLC
  SUBSTANTIALLY EQUIVALENT 1
ONENESS BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
P.G.F. INDUSTRY SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO BRIGHT MOON BIOMEDICAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RAPID NEXUS NANOTECH WOUND SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAYA PHARMACEUTICALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL INDUSTRIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROOSIN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SERIOUSLY CLEAN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIOXMED, LLC
  SUBSTANTIALLY EQUIVALENT 4
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOLVENTUM US, LLC
  SUBSTANTIALLY EQUIVALENT 1
SONOMA PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECIALITY FIBRES AND MATERIALS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM ANTIMICROBIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM ANTIMICROBIALS, INC. (SUBSIDIARY OF COLLIDION, INC.
  SUBSTANTIALLY EQUIVALENT 1
STEMCYTE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SWEETBIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
V3BIO SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
WINNER MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 139 148
2021 183 184
2022 176 185
2023 198 199
2024 232 232
2025 186 186

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 311 311
Adverse Event Without Identified Device or Use Problem 244 244
Contamination /Decontamination Problem 177 179
Unsealed Device Packaging 119 119
Device Contaminated During Manufacture or Shipping 108 108
Contamination 88 88
Insufficient Information 64 64
Packaging Problem 56 56
Patient-Device Incompatibility 47 48
Patient Device Interaction Problem 38 38
Appropriate Term/Code Not Available 28 28
Device Damaged Prior to Use 27 27
Difficult to Remove 25 25
Device Contamination with Chemical or Other Material 18 18
Material Discolored 15 16
Improper or Incorrect Procedure or Method 11 11
Loss of or Failure to Bond 10 19
No Apparent Adverse Event 10 10
Nonstandard Device 7 7
Off-Label Use 7 7
Defective Component 7 7
Biocompatibility 6 6
Physical Resistance/Sticking 6 6
Material Integrity Problem 6 6
Device Appears to Trigger Rejection 5 5
Device Handling Problem 5 5
Use of Device Problem 5 5
Material Disintegration 5 5
Lack of Effect 4 4
Material Fragmentation 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Markings/Labelling Problem 3 9
Break 3 3
Fluid/Blood Leak 3 3
Therapeutic or Diagnostic Output Failure 2 2
Separation Failure 2 2
Entrapment of Device 2 3
Improper Chemical Reaction 2 2
Device Ingredient or Reagent Problem 2 2
Adhesive Too Strong 1 1
Failure to Obtain Sample 1 1
Component Missing 1 1
Particulates 1 1
Moisture or Humidity Problem 1 1
Activation Problem 1 1
Output Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 359 359
Unspecified Infection 96 96
Skin Inflammation/ Irritation 80 80
Hypersensitivity/Allergic reaction 75 75
Bacterial Infection 62 62
Itching Sensation 54 54
Blister 53 54
No Patient Involvement 42 48
Erythema 37 37
Rash 36 36
Insufficient Information 36 45
Pain 34 34
Impaired Healing 28 28
Contact Dermatitis 23 23
Hemorrhage/Bleeding 22 22
Swelling/ Edema 21 21
Fever 18 18
Urinary Tract Infection 17 17
Local Reaction 17 17
Post Operative Wound Infection 17 17
Sepsis 16 16
Tissue Breakdown 16 16
Anaphylactic Shock 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Burn(s) 15 15
Inflammation 14 14
Skin Tears 14 14
Burning Sensation 14 14
No Known Impact Or Consequence To Patient 14 17
Death 13 13
Fluid Discharge 13 13
No Consequences Or Impact To Patient 13 13
Unspecified Tissue Injury 13 13
Skin Infection 12 12
Skin Discoloration 12 12
Low Blood Pressure/ Hypotension 11 11
Purulent Discharge 11 11
Skin Burning Sensation 10 10
Necrosis 9 9
Post Traumatic Wound Infection 9 9
Drug Resistant Bacterial Infection 8 8
Discomfort 8 8
Seroma 8 8
Hematoma 8 8
Localized Skin Lesion 8 8
Wound Dehiscence 7 7
Septic Shock 7 7
Foreign Body In Patient 7 7
Skin Erosion 6 6
Caustic/Chemical Burns 6 6

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Oct-09-2024
2 Acera Surgical Inc II May-02-2022
3 CellEra LLC III Mar-16-2022
4 ConvaTec, Inc II Dec-19-2022
5 Gentell, Inc II May-06-2020
6 Gentell, Inc II Mar-05-2020
7 Integra LifeSciences Corp. II Feb-12-2025
8 Integra LifeSciences Corp. II Oct-10-2024
9 Integra LifeSciences Corp. (NeuroSciences) II Sep-03-2025
10 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
11 MEDLINE INDUSTRIES, LP - Northfield II Jun-21-2023
12 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
13 Nurse Assist, LLC I Dec-20-2023
14 Z-Medica, LLC II Nov-05-2021
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