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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 1
3M HEALTH CARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 1
ADVAMEDICA INC.
  SUBSTANTIALLY EQUIVALENT 2
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
BIONOVA MEDICAL INC.
  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
FOSHAN UNITED MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GEL-E, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
KOAG LLC
  SUBSTANTIALLY EQUIVALENT 1
LES LABORATOIRES BROTHIER S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEBO LIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDCU TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRADE PRODUCT LTD
  SUBSTANTIALLY EQUIVALENT 1
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMEZA, LLC
  SUBSTANTIALLY EQUIVALENT 1
PLANET (SUZHOU) MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PROTEGE BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL INDUSTRIES, 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 LTD.
  SUBSTANTIALLY EQUIVALENT 2
SOLAPLUS BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
STATGUARD, LLC
  SUBSTANTIALLY EQUIVALENT 1
SWEETBIO, INC
  SUBSTANTIALLY EQUIVALENT 1
SYNEDGEN, INC
  SUBSTANTIALLY EQUIVALENT 1
V3BIO SDN. BHD
  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 7
Z-MEDICA, LLC
  SUBSTANTIALLY EQUIVALENT 1
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 257 257
Delivered as Unsterile Product 233 233
Contamination /Decontamination Problem 119 119
Unsealed Device Packaging 112 112
Device Contaminated During Manufacture or Shipping 106 106
Patient-Device Incompatibility 41 41
Device Contamination with Chemical or Other Material 35 35
Packaging Problem 28 28
Insufficient Information 27 27
Appropriate Term/Code Not Available 22 22
Material Discolored 16 16
No Apparent Adverse Event 14 14
Patient Device Interaction Problem 10 10
Loss of or Failure to Bond 10 10
Improper or Incorrect Procedure or Method 9 9
Difficult to Remove 8 8
Material Integrity Problem 8 8
Missing Value Reason 7 7
Physical Resistance/Sticking 7 7
Defective Component 7 7
Use of Device Problem 6 6
Fluid/Blood Leak 5 5
Material Fragmentation 5 5
Device Operates Differently Than Expected 5 5
Device Markings/Labelling Problem 4 4
Device Handling Problem 4 4
Peeled/Delaminated 4 4
Contamination 4 4
Material Disintegration 4 4
Device Appears to Trigger Rejection 4 4
Entrapment of Device 3 3
Sticking 2 2
Nonstandard Device 2 2
Product Quality Problem 2 2
Material Separation 1 1
Shelf Life Exceeded 1 1
Inadequate or Insufficient Training 1 1
Microbial Contamination of Device 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
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
Off-Label Use 1 1
Particulates 1 1
Labelling, Instructions for Use or Training Problem 1 1
Mechanical Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Remove Packaging Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Illegible Information 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 193 193
No Patient Involvement 102 102
Unspecified Infection 43 43
No Known Impact Or Consequence To Patient 41 41
Injury 38 38
Erythema 26 26
No Consequences Or Impact To Patient 25 25
Hypersensitivity/Allergic reaction 24 24
Death 24 24
Skin Irritation 22 22
Pain 21 21
Bacterial Infection 20 20
Itching Sensation 18 18
Rash 18 18
Impaired Healing 18 18
Reaction 17 17
Tissue Damage 17 17
Skin Inflammation/ Irritation 16 16
Tissue Breakdown 15 15
Anaphylactic Shock 14 14
Blister 13 13
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
Post Operative Wound Infection 10 10
Patient Problem/Medical Problem 9 9
Insufficient Information 9 9
Inflammation 9 9
Swelling 8 8
Local Reaction 8 8
Fluid Discharge 8 8
Foreign Body In Patient 7 7
Necrosis 7 7
Burn(s) 7 7
Caustic/Chemical Burns 6 6
Skin Inflammation 6 6
Skin Tears 6 6
Skin Infection 6 6
Contact Dermatitis 6 6
Localized Skin Lesion 5 5
Partial thickness (Second Degree) Burn 5 5
Swelling/ Edema 5 5
Joint Dislocation 5 5
Reinfusion 5 5
Cellulitis 5 5
Muscle Weakness 5 5
Nausea 5 5
Loss of Range of Motion 5 5
Skin Discoloration 5 5
Low Blood Pressure/ Hypotension 4 4
Hemorrhage/Bleeding 4 4
Full thickness (Third Degree) Burn 4 4
Device Embedded In Tissue or Plaque 4 4
Drug Resistant Bacterial Infection 3 3
Alteration in Body Temperature 3 3
Sensitivity of Teeth 3 3
Urticaria 3 3
Fever 3 3
Headache 3 3
Infiltration into Tissue 3 3
Irritation 3 3
Laceration(s) 3 3
Dyspnea 3 3
Ulceration 3 3
Tingling 3 3
Dizziness 3 3
Peeling 3 3
Renal Failure 2 2
Scar Tissue 2 2
Seizures 2 2
Vomiting 2 2
Tachycardia 2 2
Sepsis 2 2
Dehydration 2 2
Cardiac Arrest 2 2
Bruise/Contusion 2 2
Wound Dehiscence 2 2
Hematoma 2 2
Purulent Discharge 2 2
Pressure Sores 2 2
Discomfort 2 2
Loss of consciousness 2 2
Fungal Infection 2 2
Meningitis 2 2
Shaking/Tremors 2 2
Blood Loss 2 2
Skin Burning Sensation 2 2
No Information 2 2
Cancer 2 2
Convulsion/Seizure 1 1
Eye Pain 1 1
Pyogenic Infection 1 1
Unspecified Tissue Injury 1 1
Eczema 1 1
Missed Dose 1 1
Superficial (First Degree) Burn 1 1
Sleep Dysfunction 1 1
Post Traumatic Wound Infection 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 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
10 Southwest Technologies Inc II Dec-13-2019
11 Z-Medica, LLC II Nov-05-2021
12 Z-Medica, LLC II Mar-08-2018
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