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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
3M HEALTH CARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 1
ABIGO MEDICAL AB
  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 1
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
BAUSCH HEALTH AMERICAS INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
BIONOVA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTD, S.A.
  SUBSTANTIALLY EQUIVALENT 1
BU POLYSCIENCES EQUIPMENT & TRADING, LLC
  SUBSTANTIALLY EQUIVALENT 1
CLYRA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL INDUSTRIES, INC.
  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
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 1
HANGZHOU ZEO-INNOV LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
HYDROFERA, LLC
  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
KOAG LLC
  SUBSTANTIALLY EQUIVALENT 1
LES LABORATOIRES BROTHIER S.A.
  SUBSTANTIALLY EQUIVALENT 1
LS SCIENTIFIC INC. D.B.A. KSE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
MEBO LIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCU TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRADE PRODUCT LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDTRADE PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANOFIBER SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 3
OCULUS INNOVATIVE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
OMEZA, LLC
  SUBSTANTIALLY EQUIVALENT 1
PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDICS INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
POLYNOVO BIOMATERIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 2
PROTEGE BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL INDUSTRIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROOSIN MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIMPLE SCIENCE LLC
  SUBSTANTIALLY EQUIVALENT 1
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
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
VOMARIS WOUND CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WINNER MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WINNER MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
Z-MEDICA, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 148 148
2018 128 128
2019 136 136
2020 137 137
2021 179 179
2022 133 133

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 297 297
Delivered as Unsterile Product 237 237
Unsealed Device Packaging 127 127
Contamination /Decontamination Problem 101 101
Device Contaminated During Manufacture or Shipping 88 88
Patient-Device Incompatibility 57 57
Device Contamination with Chemical or Other Material 43 43
Device Operates Differently Than Expected 40 40
Insufficient Information 37 37
Packaging Problem 26 26
Appropriate Term/Code Not Available 24 24
Improper or Incorrect Procedure or Method 17 17
Material Discolored 16 16
No Apparent Adverse Event 14 14
Use of Device Problem 11 11
Material Integrity Problem 10 10
Difficult to Remove 10 10
Loss of or Failure to Bond 9 9
Missing Value Reason 9 9
Patient Device Interaction Problem 8 8
Contamination 8 8
Defective Component 7 7
Physical Resistance/Sticking 7 7
Device Handling Problem 6 6
Product Quality Problem 6 6
Material Fragmentation 6 6
Fluid Leak 5 5
Material Disintegration 5 5
Device Appears to Trigger Rejection 4 4
Peeled/Delaminated 4 4
Device Markings/Labelling Problem 4 4
Sticking 4 4
Entrapment of Device 3 3
Nonstandard Device 2 2
Leak/Splash 2 2
Material Separation 2 2
Microbial Contamination of Device 2 2
Contamination of Device Ingredient or Reagent 2 2
Detachment of Device or Device Component 1 1
Difficult to Open or Remove Packaging Material 1 1
Inadequate or Insufficient Training 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Illegible Information 1 1
Component Missing 1 1
Fungus in Device Environment 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
Shelf Life Exceeded 1 1
Increase in Pressure 1 1
Off-Label Use 1 1
Particulates 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Cross Reactivity 1 1
Decrease in Suction 1 1
Device Expiration Issue 1 1
Break 1 1
Collapse 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 171 171
No Patient Involvement 127 127
Unspecified Infection 54 54
Erythema 50 50
No Known Impact Or Consequence To Patient 49 49
Injury 40 40
Reaction 38 38
Skin Irritation 38 38
No Consequences Or Impact To Patient 33 33
Hypersensitivity/Allergic reaction 30 30
Death 25 25
Bacterial Infection 25 25
Rash 25 25
Itching Sensation 24 24
Pain 24 24
Tissue Damage 23 23
Peeling 21 21
Skin Inflammation 18 18
Impaired Healing 16 16
No Code Available 16 16
Skin Erosion 16 16
Anaphylactic Shock 15 15
Tissue Breakdown 15 15
Burning Sensation 15 15
Burn(s) 14 14
Caustic/Chemical Burns 13 13
Blister 13 13
Skin Inflammation/ Irritation 12 12
Fluid Discharge 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Ulcer 11 11
Post Operative Wound Infection 11 11
Inflammation 11 11
Skin Discoloration 11 11
Local Reaction 10 10
Necrosis 9 9
Swelling 9 9
Cellulitis 9 9
Patient Problem/Medical Problem 9 9
Insufficient Information 8 8
Foreign Body In Patient 8 8
Low Blood Pressure/ Hypotension 8 8
Irritation 7 7
Skin Tears 7 7
Discharge 6 6
Skin Infection 6 6
Localized Skin Lesion 5 5
Partial thickness (Second Degree) Burn 5 5
Joint Dislocation 5 5
Reinfusion 5 5
Hemorrhage/Bleeding 5 5
Loss of Range of Motion 5 5
Muscle Weakness 5 5
Nausea 5 5
Ulceration 4 4
Tingling 4 4
Urticaria 4 4
Full thickness (Third Degree) Burn 4 4
Device Embedded In Tissue or Plaque 4 4
No Information 4 4
Blood Loss 4 4
Contact Dermatitis 4 4
Swelling/ Edema 4 4
Alteration in Body Temperature 3 3
Drug Resistant Bacterial Infection 3 3
Discomfort 3 3
Dizziness 3 3
Fungal Infection 3 3
Sensitivity of Teeth 3 3
Tachycardia 3 3
Laceration(s) 3 3
Infiltration into Tissue 3 3
Fever 3 3
Headache 3 3
Bruise/Contusion 3 3
Abscess 3 3
Wound Dehiscence 2 2
Cardiac Arrest 2 2
Purulent Discharge 2 2
Dyspnea 2 2
Edema 2 2
Hematoma 2 2
Foreign Body Reaction 2 2
Dehydration 2 2
Renal Failure 2 2
Loss of Vision 2 2
Vomiting 2 2
Sepsis 2 2
Scar Tissue 2 2
Seizures 2 2
Collapse 2 2
Loss of consciousness 2 2
Anaphylactoid 2 2
Thrombus 2 2
Pressure Sores 2 2
Skin Burning Sensation 2 2
Shaking/Tremors 2 2
Cancer 2 2
Convulsion/Seizure 1 1
Eye Pain 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 Gentell, Inc II May-06-2020
6 Gentell, Inc II Mar-05-2020
7 Integra LifeSciences Corp. II May-04-2018
8 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
9 Southwest Technologies Inc II Dec-13-2019
10 Z-Medica, LLC II Nov-05-2021
11 Z-Medica, LLC II Mar-08-2018
12 Z-Medica, LLC II Jun-19-2017
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