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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
ACERA SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVAMEDICA INC.
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED MEDICAL SOLUTIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 2
ALLMED MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AMSINO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ARCH THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGENTUM MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ARGENTUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATTWILL MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
BC3 TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
BIONOVA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BIONOVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
GEL4MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ZEO-INNOV LIFE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HARTMANN USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9
IMBED BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 1
INNOVACYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRRIMAX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU EXCELLENCE MEDICAL SUPPLIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU NEWVALUE MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JINHUA JINGDI MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KANE BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
KERICURE INC.
  SUBSTANTIALLY EQUIVALENT 1
KOAG LLC
  SUBSTANTIALLY EQUIVALENT 1
MEBO LIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 2
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
RAYA PHARMACEUTICALS LLC
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL INDUSTRIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ROOSIN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIOXMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIOXMED, LLC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SONOMA PHARMACEUTICALS, INC.
  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 1
V3BIO SDN. BHD
  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
2020 137 137
2021 179 179
2022 177 177
2023 198 198
2024 232 232
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 280 280
Adverse Event Without Identified Device or Use Problem 224 224
Contamination /Decontamination Problem 169 169
Device Contaminated During Manufacture or Shipping 106 106
Unsealed Device Packaging 95 95
Contamination 85 85
Packaging Problem 53 53
Insufficient Information 49 49
Patient-Device Incompatibility 30 30
Appropriate Term/Code Not Available 27 27
Device Contamination with Chemical or Other Material 17 17
Difficult to Remove 14 14
Material Discolored 14 14
Patient Device Interaction Problem 12 12
No Apparent Adverse Event 10 10
Improper or Incorrect Procedure or Method 10 10
Loss of or Failure to Bond 9 9
Device Damaged Prior to Use 8 8
Defective Component 6 6
Nonstandard Device 6 6
Material Integrity Problem 6 6
Use of Device Problem 5 5
Physical Resistance/Sticking 5 5
Off-Label Use 4 4
Device Appears to Trigger Rejection 4 4
Device Handling Problem 4 4
Device Markings/Labelling Problem 3 3
Material Disintegration 3 3
Fluid/Blood Leak 3 3
Material Fragmentation 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Ingredient or Reagent Problem 2 2
Break 2 2
Separation Failure 2 2
Lack of Effect 2 2
Entrapment of Device 2 2
Failure to Obtain Sample 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Separation 1 1
Improper Chemical Reaction 1 1
Failure to Infuse 1 1
Material Split, Cut or Torn 1 1
Product Quality Problem 1 1
Increase in Pressure 1 1
Leak/Splash 1 1
Therapeutic or Diagnostic Output Failure 1 1
Adhesive Too Strong 1 1
Biocompatibility 1 1
Detachment of Device or Device Component 1 1
Fungus in Device Environment 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 317 317
Unspecified Infection 91 91
Skin Inflammation/ Irritation 60 60
Bacterial Infection 57 57
Hypersensitivity/Allergic reaction 52 52
No Patient Involvement 42 42
Blister 30 30
Itching Sensation 29 29
Impaired Healing 26 26
Pain 25 25
Erythema 24 24
Contact Dermatitis 21 21
Insufficient Information 21 21
Rash 21 21
Swelling/ Edema 18 18
Urinary Tract Infection 17 17
Fever 15 15
Local Reaction 15 15
Tissue Breakdown 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
No Known Impact Or Consequence To Patient 14 14
Anaphylactic Shock 13 13
Post Operative Wound Infection 13 13
Burn(s) 13 13
Sepsis 13 13
Death 13 13
No Consequences Or Impact To Patient 13 13
Fluid Discharge 12 12
Skin Infection 12 12
Unspecified Tissue Injury 12 12
Burning Sensation 10 10
Inflammation 10 10
Skin Discoloration 10 10
Hemorrhage/Bleeding 10 10
Skin Tears 9 9
Necrosis 9 9
Purulent Discharge 8 8
Septic Shock 8 8
Drug Resistant Bacterial Infection 7 7
Localized Skin Lesion 7 7
Hematoma 7 7
Caustic/Chemical Burns 6 6
Foreign Body In Patient 6 6
Wound Dehiscence 6 6
Skin Erosion 6 6
Injury 5 5
Seroma 5 5
Muscle Weakness 5 5
Loss of Range of Motion 5 5
Discomfort 5 5

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Oct-09-2024
2 Acera Surgical Inc II May-02-2022
3 CellEra LLC III Mar-16-2022
4 ConvaTec, Inc II Dec-19-2022
5 Gentell, Inc II May-06-2020
6 Gentell, Inc II Mar-05-2020
7 Integra LifeSciences Corp. II Oct-10-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Jun-21-2023
9 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
10 Nurse Assist, LLC I Dec-20-2023
11 Z-Medica, LLC II Nov-05-2021
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