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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device dressing, wound, drug
Product CodeFRO
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
3-D MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
3M COMPANY, 3M HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
ABIGO MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 2
ABL MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ACERA SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ADVAMEDICA INC.
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED MEDICAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 6
ALLIQUA BIOMEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
AMSINO INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
AMSINO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ANEXA BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
AQUILABS US LLC
  SUBSTANTIALLY EQUIVALENT 1
ARCH THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARGENTUM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
AROA BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
ASCENT CONSUMER PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATTWILL MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
AVERY DENNISON BELGIE BVBA
  SUBSTANTIALLY EQUIVALENT 1
AVERY DENNISON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH HEALTH AMERICAS INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
BEEKEN BIOMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOTD, S.A.
  SUBSTANTIALLY EQUIVALENT 1
BU POLYSCIENCES EQUIPMENT & TRADING, LLC
  SUBSTANTIALLY EQUIVALENT 1
CENTURY PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLYRA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CORE SCIENTIFIC CREATION LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED TISSUE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENZYSURGE LTD.
  SUBSTANTIALLY EQUIVALENT 1
EXCITON TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
EXCITON TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXELTIS USA DERMATOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN UNITED MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOUNDERS SCIENCE GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
GEL-E, INC.
  SUBSTANTIALLY EQUIVALENT 3
GEL-E, INC. (FORMERLY REMEDIUM TECHNOLOGIES, INC.)
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL HEALTH SOLUTIONS (DBA TURN THERAPEUTICS)
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL HEALTH SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 2
HELSINN HEALTHCARE SA
  SUBSTANTIALLY EQUIVALENT 1
HEMCON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
HYDROFERA, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMBED BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOTHERAPY INC.
  SUBSTANTIALLY EQUIVALENT 1
ISDIN CORP
  SUBSTANTIALLY EQUIVALENT 1
IZUN PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU EXCELLENCE MEDICAL SUPPLIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU NEWVALUE MEDICAL PRODUCST CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
LES LABORATOIRES BROTHIER S.A.
  SUBSTANTIALLY EQUIVALENT 1
LIFESCIENCEPLUS INC.
  SUBSTANTIALLY EQUIVALENT 1
LS SCIENTIFIC INC. D.B.A. KSE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
MARINE POLYMER TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEBO LIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCU TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL TECHNOLOGY RESEARCH INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRADE PRODUCT LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDTRADE PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE, US LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOFIBER SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 2
OCULUS INNOVATIVE SCIENCES
  SUBSTANTIALLY EQUIVALENT 3
OMEZA, LLC
  SUBSTANTIALLY EQUIVALENT 1
PERMEADERM, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDICS INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
POLYNOVO BIOMATERIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
PROTEGE BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL INDUSTRIES LLC
  SUBSTANTIALLY EQUIVALENT 2
ROCHAL INDUSTRIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROOSIN MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YUANXING NANO-PHARMA CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIMPLE SCIENCE LLC
  SUBSTANTIALLY EQUIVALENT 1
SIMPLE SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
SOLAPLUS BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SONOMA PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 2
SONOMA PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPECIALITY FIBRES AND MATERIALS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY FIBRES AND MATERIALS LTD
  SUBSTANTIALLY EQUIVALENT 1
STATGUARD, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRUKMYER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
SWEETBIO, INC
  SUBSTANTIALLY EQUIVALENT 1
SYNEDGEN, INC
  SUBSTANTIALLY EQUIVALENT 1
VALEANT PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
VIRCHOW BIOTECH PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
VIRCHOW BIOTECH PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
VOMARIS INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOMARIS WOUND CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WINNER MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WINNER MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
Z-MEDICA, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 147 147
2017 148 148
2018 128 128
2019 136 136
2020 137 137
2021 104 104

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 281 281
Delivered as Unsterile Product 144 144
Unsealed Device Packaging 108 108
Device Operates Differently Than Expected 65 65
Patient-Device Incompatibility 58 58
Insufficient Information 52 52
Device Contamination with Chemical or Other Material 52 52
Appropriate Term/Code Not Available 25 25
Improper or Incorrect Procedure or Method 19 19
Material Discolored 18 18
Use of Device Problem 12 12
Material Integrity Problem 11 11
Contamination /Decontamination Problem 10 10
Difficult to Remove 9 9
Loss of or Failure to Bond 9 9
Material Fragmentation 9 9
Missing Value Reason 9 9
Device Handling Problem 9 9
Packaging Problem 8 8
Patient Device Interaction Problem 7 7
Defective Component 7 7
Sticking 7 7
Product Quality Problem 7 7
Contamination 6 6
Device Packaging Compromised 6 6
No Apparent Adverse Event 5 5
Material Disintegration 5 5
Tear, Rip or Hole in Device Packaging 5 5
Physical Resistance/Sticking 5 5
Device Markings/Labelling Problem 4 4
Device Appears to Trigger Rejection 4 4
Peeled/Delaminated 4 4
Migration or Expulsion of Device 4 4
Material Separation 4 4
Hole In Material 3 3
Failure To Adhere Or Bond 3 3
Entrapment of Device 3 3
Material Frayed 3 3
Device Contaminated During Manufacture or Shipping 3 3
Contamination of Device Ingredient or Reagent 2 2
Leak/Splash 2 2
Detachment Of Device Component 2 2
Nonstandard Device 2 2
Microbial Contamination of Device 2 2
Fluid Leak 2 2
Defective Device 2 2
Particulates 1 1
Off-Label Use 1 1
Difficult to Open or Remove Packaging Material 1 1
Deformation Due to Compressive Stress 1 1
Detachment of Device or Device Component 1 1
Illegible Information 1 1
Patient Data Problem 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Shelf Life Exceeded 1 1
Device Slipped 1 1
Inadequate or Insufficient Training 1 1
Inadequate Instructions for Healthcare Professional 1 1
Device Expiration Issue 1 1
Break 1 1
Collapse 1 1
Decrease in Suction 1 1
Unexpected Therapeutic Results 1 1
Fungus in Device Environment 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 152 152
No Known Impact Or Consequence To Patient 73 73
Erythema 54 54
Unspecified Infection 54 54
Reaction 48 48
Skin Irritation 47 47
Injury 42 42
Rash 40 40
No Clinical Signs, Symptoms or Conditions 39 39
Itching Sensation 39 39
No Consequences Or Impact To Patient 37 37
Hypersensitivity/Allergic reaction 32 32
Pain 32 32
Tissue Damage 31 31
Death 25 25
Skin Inflammation 24 24
Peeling 21 21
No Code Available 21 21
Burn(s) 18 18
Burning Sensation 17 17
Tissue Breakdown 16 16
Anaphylactic Shock 16 16
Caustic/Chemical Burns 16 16
Swelling 16 16
Skin Erosion 14 14
Fluid Discharge 14 14
Bacterial Infection 13 13
Ulcer 12 12
Skin Discoloration 11 11
Irritation 11 11
Discharge 10 10
Cellulitis 10 10
Local Reaction 10 10
Necrosis 10 10
Foreign Body In Patient 10 10
Impaired Healing 10 10
Post Operative Wound Infection 9 9
Patient Problem/Medical Problem 9 9
Inflammation 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Skin Tears 8 8
Low Blood Pressure/ Hypotension 6 6
Skin Inflammation/ Irritation 6 6
No Information 6 6
Reinfusion 5 5
Nausea 5 5
Hemorrhage/Bleeding 5 5
Muscle Weakness 5 5
Loss of Range of Motion 5 5
Fever 5 5
Joint Dislocation 5 5
Pressure Sores 4 4
Ulceration 4 4
Partial thickness (Second Degree) Burn 4 4
Tingling 4 4
Blood Loss 4 4
Device Embedded In Tissue or Plaque 4 4
Blister 4 4
Localized Skin Lesion 3 3
Skin Infection 3 3
Full thickness (Third Degree) Burn 3 3
Dizziness 3 3
Discomfort 3 3
Urticaria 3 3
Headache 3 3
Bruise/Contusion 3 3
Seizures 3 3
Fungal Infection 3 3
Sensitivity of Teeth 3 3
Hematoma 3 3
Dyspnea 3 3
Abscess 3 3
Infiltration into Tissue 3 3
Insufficient Information 3 3
Renal Failure 2 2
Increased Sensitivity 2 2
Dehydration 2 2
Gangrene 2 2
Cancer 2 2
Skin Burning Sensation 2 2
Contact Dermatitis 2 2
Chills 2 2
Anaphylactoid 2 2
Thrombus 2 2
Wheal(s) 2 2
Collapse 2 2
Loss of consciousness 2 2
Tachycardia 2 2
Loss of Vision 2 2
Vomiting 2 2
Purulent Discharge 2 2
Edema 2 2
Foreign Body Reaction 2 2
Shaking/Tremors 2 2
Swelling/ Edema 2 2
Unspecified Tissue Injury 1 1
Missing Value Reason 1 1
Eye Pain 1 1
Distress 1 1
Therapeutic Response, Decreased 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Medical Solutions Ltd. II Sep-02-2016
2 Anika Therapeutics, Inc. II Jul-11-2018
3 CareFusion 303, Inc. II Mar-24-2016
4 Conseal International, Inc. II May-03-2018
5 Gentell, Inc II May-06-2020
6 Gentell, Inc II Mar-05-2020
7 Integra LifeSciences Corp. II May-04-2018
8 Medical Action Industries Inc II Mar-02-2016
9 Oculus Innovative Sciences, Inc. II Dec-14-2016
10 Southwest Technologies Inc II Dec-13-2019
11 TZ Medical, Inc. II Oct-21-2016
12 Z-Medica, LLC II Mar-08-2018
13 Z-Medica, LLC II Jun-19-2017
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