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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 2
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 6
HYDROFERA, LLC
  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
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 1
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 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 197 197
2024 166 166

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 307 307
Adverse Event Without Identified Device or Use Problem 250 250
Contamination /Decontamination Problem 165 165
Unsealed Device Packaging 124 124
Device Contaminated During Manufacture or Shipping 106 106
Contamination 82 82
Packaging Problem 53 53
Insufficient Information 49 49
Patient-Device Incompatibility 34 34
Appropriate Term/Code Not Available 31 31
Device Contamination with Chemical or Other Material 28 28
Material Discolored 16 16
Patient Device Interaction Problem 15 15
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
Defective Component 7 7
Physical Resistance/Sticking 7 7
Material Integrity Problem 7 7
Device Damaged Prior to Use 6 6
Nonstandard Device 6 6
Use of Device Problem 6 6
Material Fragmentation 5 5
Fluid/Blood Leak 5 5
Device Appears to Trigger Rejection 4 4
Device Markings/Labelling Problem 4 4
Device Handling Problem 4 4
Entrapment of Device 4 4
Peeled/Delaminated 4 4
Off-Label Use 4 4
Material Disintegration 4 4
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
Failure to Obtain Sample 1 1
Therapeutic or Diagnostic Output Failure 1 1
Illegible Information 1 1
Improper Chemical Reaction 1 1
Failure to Infuse 1 1
Component Missing 1 1
Inadequate or Insufficient Training 1 1
Decrease in Suction 1 1
Tear, Rip or Hole in Device Packaging 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Separation 1 1
Biocompatibility 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 303 303
No Patient Involvement 81 81
Unspecified Infection 80 80
Bacterial Infection 54 54
Skin Inflammation/ Irritation 52 52
Hypersensitivity/Allergic reaction 44 44
No Known Impact Or Consequence To Patient 32 32
Pain 28 28
Erythema 28 28
Blister 27 27
Impaired Healing 24 24
Itching Sensation 21 21
Contact Dermatitis 20 20
Injury 20 20
Death 19 19
No Consequences Or Impact To Patient 19 19
Local Reaction 17 17
Rash 17 17
Anaphylactic Shock 16 16
Fever 16 16
Swelling/ Edema 16 16
Urinary Tract Infection 16 16
Tissue Breakdown 15 15
Insufficient Information 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Post Operative Wound Infection 14 14
Fluid Discharge 14 14
Sepsis 14 14
Tissue Damage 13 13
Burn(s) 12 12
Skin Infection 12 12
Inflammation 11 11
Burning Sensation 10 10
Necrosis 10 10
No Code Available 10 10
Skin Discoloration 9 9
Unspecified Tissue Injury 9 9
Purulent Discharge 7 7
Septic Shock 7 7
Drug Resistant Bacterial Infection 7 7
Cellulitis 7 7
Localized Skin Lesion 7 7
Foreign Body In Patient 7 7
Caustic/Chemical Burns 6 6
Skin Tears 6 6
Skin Irritation 6 6
Hemorrhage/Bleeding 6 6
Skin Erosion 6 6
Joint Dislocation 5 5
Seroma 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Acera Surgical Inc II May-02-2022
2 CellEra LLC III Mar-16-2022
3 ConvaTec, Inc II Dec-19-2022
4 Gentell, Inc II May-06-2020
5 Gentell, Inc II Mar-05-2020
6 MEDLINE INDUSTRIES, LP - Northfield II Jun-21-2023
7 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
8 Nurse Assist, LLC I Dec-20-2023
9 Southwest Technologies Inc II Dec-13-2019
10 Z-Medica, LLC II Nov-05-2021
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