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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
3M HEALTHCARE BUSINESS GROUP
  SUBSTANTIALLY EQUIVALENT 1
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
ARGENTUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGENTUM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KREATE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIONOVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLOPLAST CORP.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN UNITED MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GEL4MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
HARTMANN USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU FORYOU MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
IMBED BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 1
INFECTION ELIMINATION SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOVACORIUM, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVACYN, INC.
  SUBSTANTIALLY EQUIVALENT 2
IRRIMAX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU EXCELLENCE MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JINHUA JINGDI MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KANE BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
KERICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
LABORATORIOS BIOGALENIC S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
LETUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEBO LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMEZA, LLC
  SUBSTANTIALLY EQUIVALENT 1
ONENESS BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
P.G.F. INDUSTRY SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO BRIGHT MOON BIOMEDICAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
RAPID NEXUS NANOTECH WOUND SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAYA PHARMACEUTICALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROOSIN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SERIOUSLY CLEAN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SILK HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SILVERCEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIOXMED, LLC
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOLVENTUM GERMANY GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOLVENTUM US, LLC
  SUBSTANTIALLY EQUIVALENT 1
SONOMA PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPECIALITY FIBRES AND MATERIALS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM ANTIMICROBIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM ANTIMICROBIALS, INC. (SUBSIDIARY OF COLLIDION, INC.
  SUBSTANTIALLY EQUIVALENT 1
STEMCYTE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SWEETBIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
URGO MEDICAL NORTH AMERICA, LLC
  SUBSTANTIALLY EQUIVALENT 1
V3BIO SDN. BHD
  SUBSTANTIALLY EQUIVALENT 1
WINNER MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9

MDR Year MDR Reports MDR Events
2021 183 184
2022 176 185
2023 198 199
2024 232 232
2025 194 194
2026 151 151

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 309 309
Contamination /Decontamination Problem 189 189
Adverse Event Without Identified Device or Use Problem 178 178
Insufficient Device Problem Information 115 115
Device Contaminated During Manufacture or Shipping 106 106
Unsealed Device Packaging 101 101
Contamination 86 86
Packaging Problem 55 55
Patient Device Interaction Problem 40 40
Appropriate Device Problem Term/Code Not Available 29 29
Device Damaged Prior to Use 29 29
Patient-Device Incompatibility 28 28
Difficult to Remove 23 23
Improper or Incorrect Procedure or Method 20 20
No Apparent Adverse Event 10 10
Nonstandard Device 9 9
Adhesive Too Strong 9 9
Device Damaged Prior to Receipt by User 8 8
Loss of or Failure to Bond 7 7
Off-Label Use 7 7
Device Contamination with Chemical or Other Material 6 6
Biocompatibility 4 4
Device Handling Problem 4 4
Lack of Effect 4 4
Material Fragmentation 4 4
Material Integrity Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Use of Device Problem 3 3
Material Disintegration 3 3
Physical Resistance/Sticking 3 3
Fluid/Blood Leak 3 3
Material Discolored 2 2
Break 2 2
Device Appears to Trigger Rejection 2 2
Improper Chemical Reaction 2 2
Device Ingredient or Reagent Problem 2 2
Material Too Rigid or Stiff 1 1
Failure to Obtain Sample 1 1
Particulates 1 1
Defective Component 1 1
Separation Failure 1 1
Activation Problem 1 1
Mechanical Problem 1 1
Entrapment of Device 1 2
Device Emits Odor 1 1
Product Quality Problem 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Separation Problem 1 1
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 393 393
Unspecified Infection 123 123
Skin Inflammation/ Irritation 88 88
Hypersensitivity/Allergic reaction 78 78
Bacterial Infection 73 73
Blister 62 63
Itching Sensation 56 56
Insufficient Information 50 59
Erythema 39 39
Impaired Healing 37 37
Pain 37 37
Rash 36 36
Swelling/ Edema 27 27
Hemorrhage/Blood Loss/Bleeding 26 26
Contact Dermatitis 26 26
Burn(s) 21 21
Post Operative Wound Infection 19 19
Fever 18 18
Urinary Tract Infection 18 18
Sepsis 18 18
Local Reaction 16 16
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 15 15
Fluid Discharge 15 15
Skin Tears 15 15
Tissue Breakdown 14 14
Purulent Discharge 13 13
Burning Sensation 13 13
Anaphylactic Shock 13 13
Skin Discoloration 13 13
Unspecified Tissue Injury 12 12
Skin Infection 12 12
Low Blood Pressure/ Hypotension 12 12
Wound Infection 11 11
Skin Burning Sensation 10 10
Inflammation 10 10
Drug Resistant Bacterial Infection 9 9
Wound Dehiscence 9 9
Necrosis 8 8
Septic Shock 8 8
Seroma 8 8
Medical device site infection 8 8
Discomfort 8 8
Caustic/Chemical Burns 7 7
Hematoma 7 7
Foreign Body In Patient 7 7
Skin Erosion 7 7
Scar Tissue 7 7
Nausea 6 6
Localized Skin Lesion 6 6
Cellulitis 6 6

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 Jul-07-2026
5 ConvaTec, Inc II Dec-19-2022
6 Integra LifeSciences Corp. II Feb-12-2025
7 Integra LifeSciences Corp. II Oct-10-2024
8 Integra LifeSciences Corp. (NeuroSciences) II Feb-13-2026
9 Integra LifeSciences Corp. (NeuroSciences) II Sep-03-2025
10 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
11 MEDLINE INDUSTRIES, LP - Northfield II Jun-21-2023
12 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
13 Medline Industries, LP II Feb-20-2026
14 Nurse Assist, LLC I Dec-20-2023
15 Oculus Technologies of Mexico, S.A. de C.V. II Jun-01-2026
16 Z-Medica, LLC II Nov-05-2021
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