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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 4
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 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
BIONOVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLYRA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
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
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 6
HYDROFERA, LLC
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU EXCELLENCE MEDICAL SUPPLIES 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
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
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
ROOSIN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIOXMED, LLC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
SPECIALITY FIBRES AND MATERIALS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM ANTIMICROBIALS, INC. (SUBSIDIARY OF COLLIDION, INC.
  SUBSTANTIALLY EQUIVALENT 1
STEMCYTE INC.
  SUBSTANTIALLY EQUIVALENT 2
SWEETBIO, INC
  SUBSTANTIALLY EQUIVALENT 2
V3BIO SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
WINNER MEDICAL CO., LTD
  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
2019 136 136
2020 137 137
2021 179 179
2022 177 177
2023 196 196
2024 78 78

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 298 298
Adverse Event Without Identified Device or Use Problem 247 247
Contamination /Decontamination Problem 159 159
Unsealed Device Packaging 123 123
Device Contaminated During Manufacture or Shipping 106 106
Contamination 56 56
Packaging Problem 52 52
Insufficient Information 38 38
Patient-Device Incompatibility 34 34
Device Contamination with Chemical or Other Material 28 28
Appropriate Term/Code Not Available 23 23
Material Discolored 16 16
Patient Device Interaction Problem 13 13
Difficult to Remove 11 11
Improper or Incorrect Procedure or Method 10 10
Loss of or Failure to Bond 10 10
No Apparent Adverse Event 10 10
Material Integrity Problem 7 7
Physical Resistance/Sticking 7 7
Defective Component 7 7
Use of Device Problem 5 5
Fluid/Blood Leak 5 5
Material Fragmentation 5 5
Material Disintegration 4 4
Peeled/Delaminated 4 4
Device Damaged Prior to Use 4 4
Device Appears to Trigger Rejection 4 4
Device Handling Problem 4 4
Device Markings/Labelling Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Nonstandard Device 3 3
Off-Label Use 3 3
Entrapment of Device 3 3
Break 2 2
Device Ingredient or Reagent Problem 2 2
Lack of Effect 2 2
Illegible Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Open or Remove Packaging Material 1 1
Improper Chemical Reaction 1 1
Detachment of Device or Device Component 1 1
Biocompatibility 1 1
Material Separation 1 1
Inadequate or Insufficient Training 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
Failure to Obtain Sample 1 1
Separation Failure 1 1
Cross Reactivity 1 1
Decrease in Suction 1 1
Labelling, Instructions for Use or Training Problem 1 1
Mechanical Problem 1 1
Particulates 1 1
Product Quality Problem 1 1
Increase in Pressure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 293 293
No Patient Involvement 81 81
Unspecified Infection 70 70
Bacterial Infection 49 49
Skin Inflammation/ Irritation 42 42
Hypersensitivity/Allergic reaction 33 33
No Known Impact Or Consequence To Patient 32 32
Erythema 25 25
Pain 25 25
Impaired Healing 21 21
Injury 20 20
Blister 20 20
No Consequences Or Impact To Patient 19 19
Death 19 19
Itching Sensation 17 17
Contact Dermatitis 16 16
Tissue Breakdown 15 15
Anaphylactic Shock 15 15
Rash 15 15
Fever 14 14
Insufficient Information 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Sepsis 13 13
Tissue Damage 13 13
Swelling/ Edema 12 12
Skin Infection 12 12
Fluid Discharge 12 12
Post Operative Wound Infection 10 10
No Code Available 10 10
Necrosis 10 10
Inflammation 10 10
Local Reaction 9 9
Urinary Tract Infection 9 9
Burning Sensation 9 9
Skin Discoloration 8 8
Burn(s) 8 8
Unspecified Tissue Injury 8 8
Drug Resistant Bacterial Infection 7 7
Cellulitis 7 7
Septic Shock 7 7
Skin Irritation 6 6
Purulent Discharge 6 6
Hemorrhage/Bleeding 6 6
Localized Skin Lesion 6 6
Skin Burning Sensation 5 5
Caustic/Chemical Burns 5 5
Foreign Body In Patient 5 5
Joint Dislocation 5 5
Fungal Infection 5 5
Hematoma 5 5
Wound Dehiscence 5 5
Skin Erosion 5 5
Loss of Range of Motion 5 5
Muscle Weakness 5 5
Nausea 4 4
Seroma 4 4
Scar Tissue 4 4
Reaction 4 4
Discomfort 4 4
Partial thickness (Second Degree) Burn 4 4
Skin Tears 4 4
Post Traumatic Wound Infection 3 3
Sensitivity of Teeth 3 3
Full thickness (Third Degree) Burn 3 3
Device Embedded In Tissue or Plaque 3 3
Deformity/ Disfigurement 3 3
Ulcer 3 3
Cancer 3 3
Alteration in Body Temperature 3 3
Renal Failure 3 3
Swelling 3 3
Tachycardia 3 3
Dyspnea 3 3
Cardiac Arrest 3 3
Foreign Body Sensation in Eye 3 3
Headache 3 3
Low Blood Pressure/ Hypotension 3 3
Failure of Implant 2 2
Infiltration into Tissue 2 2
Laceration(s) 2 2
Dehydration 2 2
Abscess 2 2
Bruise/Contusion 2 2
Ulceration 2 2
Vomiting 2 2
Peeling 2 2
Irritation 2 2
Pneumonia 2 2
Urticaria 2 2
Excessive Tear Production 2 2
Depression 2 2
Malaise 2 2
Meningitis 2 2
Reinfusion 2 2
Loss of consciousness 2 2
Respiratory Tract Infection 2 2
Patient Problem/Medical Problem 2 2
Superficial (First Degree) Burn 1 1
Skin Inflammation 1 1
Sleep Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acera Surgical Inc II May-02-2022
2 CellEra LLC III Mar-16-2022
3 ConvaTec, Inc II Dec-19-2022
4 Gentell, Inc II May-06-2020
5 Gentell, Inc II Mar-05-2020
6 MEDLINE INDUSTRIES, LP - Northfield II Jun-21-2023
7 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
8 Nurse Assist, LLC I Dec-20-2023
9 Southwest Technologies Inc II Dec-13-2019
10 Z-Medica, LLC II Nov-05-2021
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