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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 HEALTH CARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 1
ACERA SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVAMEDICA INC.
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED MEDICAL SOLUTIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 5
AMSINO INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
AMSINO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
AQUILABS US LLC
  SUBSTANTIALLY EQUIVALENT 1
ARCH THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARGENTUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGENTUM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ASCENT CONSUMER PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATTWILL MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH HEALTH AMERICAS INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
BC3 TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
BIONOVA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CLYRA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CRESILON, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENZYSURGE LTD.
  SUBSTANTIALLY EQUIVALENT 1
EXCITON TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN UNITED MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL HEALTH SOLUTIONS (DBA TURN THERAPEUTICS)
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ZEO-INNOV LIFE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
HYDROFERA, LLC
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU EXCELLENCE MEDICAL SUPPLIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU NEWVALUE MEDICAL PRODUCST CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU NEWVALUE MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KANE BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOAG LLC
  SUBSTANTIALLY EQUIVALENT 1
MEBO LIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDCU TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMEZA, LLC
  SUBSTANTIALLY EQUIVALENT 1
PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO BRIGHT MOON BIOMEDICAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL INDUSTRIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ROOSIN MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIMPLE SCIENCE LLC
  SUBSTANTIALLY EQUIVALENT 1
SIOXMED, LLC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
SONOMA PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECIALITY FIBRES AND MATERIALS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY FIBRES AND MATERIALS LTD
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM ANTIMICROBIALS, INC. (SUBSIDIARY OF COLLIDION, INC.
  SUBSTANTIALLY EQUIVALENT 1
STEMCYTE INC.
  SUBSTANTIALLY EQUIVALENT 1
SWEETBIO, INC
  SUBSTANTIALLY EQUIVALENT 1
SYNEDGEN, INC
  SUBSTANTIALLY EQUIVALENT 1
V3BIO SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
VALEANT PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 1
VIRCHOW BIOTECH PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
VOMARIS WOUND CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WINNER MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WINNER MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9
ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 128 128
2019 136 136
2020 137 137
2021 179 179
2022 177 177
2023 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 288 288
Adverse Event Without Identified Device or Use Problem 276 276
Contamination /Decontamination Problem 153 153
Unsealed Device Packaging 131 131
Device Contaminated During Manufacture or Shipping 107 107
Packaging Problem 48 48
Patient-Device Incompatibility 43 43
Insufficient Information 37 37
Device Contamination with Chemical or Other Material 35 35
Appropriate Term/Code Not Available 26 26
Material Discolored 16 16
No Apparent Adverse Event 14 14
Patient Device Interaction Problem 12 12
Improper or Incorrect Procedure or Method 12 12
Loss of or Failure to Bond 10 10
Difficult to Remove 9 9
Material Integrity Problem 9 9
Missing Value Reason 7 7
Physical Resistance/Sticking 7 7
Defective Component 7 7
Use of Device Problem 6 6
Device Operates Differently Than Expected 5 5
Fluid/Blood Leak 5 5
Material Fragmentation 5 5
Peeled/Delaminated 4 4
Contamination 4 4
Material Disintegration 4 4
Device Appears to Trigger Rejection 4 4
Device Handling Problem 4 4
Device Markings/Labelling Problem 4 4
Nonstandard Device 3 3
Off-Label Use 3 3
Entrapment of Device 3 3
Product Quality Problem 2 2
Sticking 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Open or Remove Packaging Material 1 1
Improper Chemical Reaction 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Illegible Information 1 1
Lack of Effect 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inadequate or Insufficient Training 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Fungus in Device Environment 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Expiration Date Error 1 1
Failure to Obtain Sample 1 1
Separation Failure 1 1
Device Expiration Issue 1 1
Cross Reactivity 1 1
Decrease in Suction 1 1
Collapse 1 1
Detachment Of Device Component 1 1
Increase in Pressure 1 1
Particulates 1 1
Labelling, Instructions for Use or Training Problem 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 252 252
No Patient Involvement 102 102
Unspecified Infection 54 54
No Known Impact Or Consequence To Patient 41 41
Injury 38 38
Hypersensitivity/Allergic reaction 29 29
Erythema 29 29
No Consequences Or Impact To Patient 25 25
Skin Inflammation/ Irritation 25 25
Death 24 24
Pain 23 23
Skin Irritation 22 22
Itching Sensation 20 20
Bacterial Infection 20 20
Impaired Healing 20 20
Rash 18 18
Tissue Damage 17 17
Anaphylactic Shock 17 17
Reaction 17 17
Tissue Breakdown 17 17
Blister 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
No Code Available 11 11
Ulcer 11 11
Burning Sensation 11 11
Skin Erosion 10 10
Necrosis 10 10
Post Operative Wound Infection 10 10
Patient Problem/Medical Problem 9 9
Fluid Discharge 9 9
Insufficient Information 9 9
Inflammation 9 9
Burn(s) 8 8
Local Reaction 8 8
Skin Discoloration 8 8
Swelling 8 8
Contact Dermatitis 8 8
Foreign Body In Patient 7 7
Partial thickness (Second Degree) Burn 6 6
Skin Infection 6 6
Swelling/ Edema 6 6
Skin Inflammation 6 6
Skin Tears 6 6
Caustic/Chemical Burns 6 6
Cellulitis 6 6
Hemorrhage/Bleeding 5 5
Loss of Range of Motion 5 5
Muscle Weakness 5 5
Nausea 5 5
Joint Dislocation 5 5
Reinfusion 5 5
Localized Skin Lesion 5 5
Full thickness (Third Degree) Burn 4 4
Device Embedded In Tissue or Plaque 4 4
Urticaria 4 4
Peeling 4 4
Low Blood Pressure/ Hypotension 4 4
Dyspnea 4 4
Cardiac Arrest 3 3
Infiltration into Tissue 3 3
Purulent Discharge 3 3
Headache 3 3
Hematoma 3 3
Fever 3 3
Laceration(s) 3 3
Irritation 3 3
Ulceration 3 3
Tingling 3 3
Dizziness 3 3
Sensitivity of Teeth 3 3
Skin Burning Sensation 3 3
Alteration in Body Temperature 3 3
Drug Resistant Bacterial Infection 3 3
Unspecified Tissue Injury 2 2
Cancer 2 2
No Information 2 2
Shaking/Tremors 2 2
Blood Loss 2 2
Loss of consciousness 2 2
Fungal Infection 2 2
Pressure Sores 2 2
Meningitis 2 2
Vomiting 2 2
Discomfort 2 2
Tachycardia 2 2
Sepsis 2 2
Scar Tissue 2 2
Seizures 2 2
Renal Failure 2 2
Pleural Effusion 2 2
Dehydration 2 2
Bruise/Contusion 2 2
Wound Dehiscence 2 2
Pulmonary Embolism 1 1
Abscess 1 1
Adhesion(s) 1 1
Airway Obstruction 1 1
Anemia 1 1
Diarrhea 1 1
Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acera Surgical Inc II May-02-2022
2 Anika Therapeutics, Inc. II Jul-11-2018
3 CellEra LLC III Mar-16-2022
4 Conseal International, Inc. II May-03-2018
5 ConvaTec, Inc II Dec-19-2022
6 Gentell, Inc II May-06-2020
7 Gentell, Inc II Mar-05-2020
8 Integra LifeSciences Corp. II May-04-2018
9 MEDLINE INDUSTRIES, LP - Northfield II Jun-21-2023
10 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
11 Southwest Technologies Inc II Dec-13-2019
12 Z-Medica, LLC II Nov-05-2021
13 Z-Medica, LLC II Mar-08-2018
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