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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 LLC
  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 3
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
FOSHAN UNITED MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GEL4MED, INC.
  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 8
HYDROFERA, LLC
  SUBSTANTIALLY EQUIVALENT 1
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, 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
RAYA PHARMACEUTICALS LLC
  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 1
SIOXMED, LLC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
SONOMA PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECIALITY FIBRES AND MATERIALS LTD.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM ANTIMICROBIALS, INC. (SUBSIDIARY OF COLLIDION, INC.
  SUBSTANTIALLY EQUIVALENT 1
STEMCYTE INC.
  SUBSTANTIALLY EQUIVALENT 2
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 198 198
2024 219 219

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 309 309
Adverse Event Without Identified Device or Use Problem 269 269
Contamination /Decontamination Problem 165 165
Unsealed Device Packaging 125 125
Device Contaminated During Manufacture or Shipping 106 106
Contamination 84 84
Insufficient Information 56 56
Packaging Problem 54 54
Patient-Device Incompatibility 34 34
Appropriate Term/Code Not Available 32 32
Device Contamination with Chemical or Other Material 28 28
Material Discolored 16 16
Patient Device Interaction Problem 16 16
Difficult to Remove 14 14
Improper or Incorrect Procedure or Method 11 11
Loss of or Failure to Bond 10 10
No Apparent Adverse Event 10 10
Material Integrity Problem 8 8
Physical Resistance/Sticking 7 7
Device Damaged Prior to Use 7 7
Use of Device Problem 7 7
Defective Component 7 7
Nonstandard Device 6 6
Fluid/Blood Leak 5 5
Material Fragmentation 5 5
Device Appears to Trigger Rejection 4 4
Device Handling Problem 4 4
Material Disintegration 4 4
Device Markings/Labelling Problem 4 4
Peeled/Delaminated 4 4
Off-Label Use 4 4
Entrapment of Device 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Separation Failure 2 2
Lack of Effect 2 2
Break 2 2
Device Ingredient or Reagent Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Adhesive Too Strong 1 1
Failure to Obtain Sample 1 1
Component Missing 1 1
Decrease in Suction 1 1
Particulates 1 1
Difficult to Open or Remove Packaging Material 1 1
Mechanical Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 309 309
Unspecified Infection 96 96
No Patient Involvement 81 81
Skin Inflammation/ Irritation 57 57
Bacterial Infection 55 55
Hypersensitivity/Allergic reaction 47 47
No Known Impact Or Consequence To Patient 32 32
Pain 30 30
Erythema 30 30
Blister 29 29
Impaired Healing 24 24
Itching Sensation 24 24
Injury 20 20
Contact Dermatitis 20 20
Death 19 19
No Consequences Or Impact To Patient 19 19
Insufficient Information 18 18
Rash 18 18
Swelling/ Edema 17 17
Local Reaction 17 17
Urinary Tract Infection 16 16
Fever 16 16
Anaphylactic Shock 16 16
Tissue Breakdown 15 15
Sepsis 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Fluid Discharge 14 14
Post Operative Wound Infection 14 14
Burn(s) 13 13
Tissue Damage 13 13
Skin Infection 12 12
Hemorrhage/Bleeding 12 12
Burning Sensation 11 11
Unspecified Tissue Injury 11 11
Inflammation 11 11
Skin Discoloration 10 10
Skin Tears 10 10
Necrosis 10 10
No Code Available 10 10
Septic Shock 8 8
Purulent Discharge 7 7
Localized Skin Lesion 7 7
Hematoma 7 7
Cellulitis 7 7
Foreign Body In Patient 7 7
Drug Resistant Bacterial Infection 7 7
Caustic/Chemical Burns 6 6
Skin Irritation 6 6
Skin Erosion 6 6
Muscle Weakness 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 Southwest Technologies Inc II Dec-13-2019
12 Z-Medica, LLC II Nov-05-2021
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