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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
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 1
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 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 295 295
Adverse Event Without Identified Device or Use Problem 246 246
Contamination /Decontamination Problem 157 157
Unsealed Device Packaging 122 122
Device Contaminated During Manufacture or Shipping 106 106
Packaging Problem 52 52
Contamination 50 50
Insufficient Information 37 37
Patient-Device Incompatibility 34 34
Device Contamination with Chemical or Other Material 28 28
Appropriate Term/Code Not Available 22 22
Material Discolored 16 16
Patient Device Interaction Problem 12 12
No Apparent Adverse Event 10 10
Loss of or Failure to Bond 10 10
Improper or Incorrect Procedure or Method 10 10
Difficult to Remove 10 10
Defective Component 7 7
Physical Resistance/Sticking 7 7
Material Integrity Problem 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 Appears to Trigger Rejection 4 4
Device Damaged Prior to Use 4 4
Device Markings/Labelling Problem 4 4
Device Handling Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Off-Label Use 3 3
Entrapment of Device 3 3
Break 2 2
Nonstandard Device 2 2
Lack of Effect 2 2
Illegible Information 1 1
Improper Chemical Reaction 1 1
Therapeutic or Diagnostic Output Failure 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
Difficult to Open or Remove Packaging Material 1 1
Detachment of Device or Device Component 1 1
Biocompatibility 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 287 287
No Patient Involvement 81 81
Unspecified Infection 66 66
Bacterial Infection 45 45
Skin Inflammation/ Irritation 37 37
No Known Impact Or Consequence To Patient 32 32
Hypersensitivity/Allergic reaction 32 32
Erythema 24 24
Pain 23 23
Injury 20 20
Impaired Healing 20 20
No Consequences Or Impact To Patient 19 19
Death 19 19
Blister 18 18
Itching Sensation 16 16
Anaphylactic Shock 15 15
Rash 15 15
Contact Dermatitis 15 15
Tissue Breakdown 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Sepsis 13 13
Tissue Damage 13 13
Fever 12 12
Skin Infection 12 12
Insufficient Information 11 11
Fluid Discharge 11 11
Post Operative Wound Infection 10 10
No Code Available 10 10
Necrosis 10 10
Local Reaction 9 9
Urinary Tract Infection 9 9
Burning Sensation 9 9
Inflammation 9 9
Swelling/ Edema 9 9
Unspecified Tissue Injury 8 8
Burn(s) 8 8
Skin Discoloration 8 8
Septic Shock 7 7
Cellulitis 7 7
Drug Resistant Bacterial Infection 7 7
Localized Skin Lesion 6 6
Hemorrhage/Bleeding 6 6
Skin Irritation 6 6
Skin Erosion 5 5
Loss of Range of Motion 5 5
Muscle Weakness 5 5
Purulent Discharge 5 5
Wound Dehiscence 5 5
Skin Burning Sensation 5 5
Caustic/Chemical Burns 5 5
Foreign Body In Patient 5 5
Joint Dislocation 5 5
Fungal Infection 5 5
Reaction 4 4
Discomfort 4 4
Partial thickness (Second Degree) Burn 4 4
Skin Tears 4 4
Hematoma 4 4
Nausea 4 4
Scar Tissue 4 4
Renal Failure 3 3
Swelling 3 3
Tachycardia 3 3
Foreign Body Sensation in Eye 3 3
Headache 3 3
Low Blood Pressure/ Hypotension 3 3
Dyspnea 3 3
Cardiac Arrest 3 3
Sensitivity of Teeth 3 3
Full thickness (Third Degree) Burn 3 3
Device Embedded In Tissue or Plaque 3 3
Ulcer 3 3
Cancer 3 3
Alteration in Body Temperature 3 3
Urticaria 2 2
Excessive Tear Production 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
Post Traumatic Wound Infection 2 2
Dehydration 2 2
Bruise/Contusion 2 2
Failure of Implant 2 2
Infiltration into Tissue 2 2
Laceration(s) 2 2
Ulceration 2 2
Vomiting 2 2
Seroma 2 2
Peeling 2 2
Irritation 2 2
Pneumonia 2 2
Pleural Effusion 1 1
Nerve Damage 1 1
Increased Sensitivity 1 1
Staphylococcus Aureus 1 1
Discharge 1 1
Hot Flashes/Flushes 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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