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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 1
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
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMEZA, LLC
  SUBSTANTIALLY EQUIVALENT 1
ONENESS BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
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 2
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
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 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 286 286
Adverse Event Without Identified Device or Use Problem 192 192
Contamination /Decontamination Problem 176 176
Device Contaminated During Manufacture or Shipping 108 108
Unsealed Device Packaging 91 91
Insufficient Information 90 90
Contamination 88 88
Packaging Problem 56 56
Patient-Device Incompatibility 44 45
Patient Device Interaction Problem 41 41
Appropriate Term/Code Not Available 28 28
Device Damaged Prior to Use 27 27
Difficult to Remove 25 25
Nonstandard Device 12 12
Improper or Incorrect Procedure or Method 11 11
No Apparent Adverse Event 10 10
Off-Label Use 7 7
Device Contamination with Chemical or Other Material 7 7
Use of Device Problem 7 7
Biocompatibility 6 6
Loss of or Failure to Bond 6 15
Device Appears to Trigger Rejection 5 5
Lack of Effect 5 5
Material Disintegration 5 5
Physical Resistance/Sticking 5 5
Adhesive Too Strong 4 4
Device Handling Problem 4 4
Material Integrity Problem 3 3
Material Fragmentation 3 3
Material Discolored 3 3
Break 3 3
Fluid/Blood Leak 3 3
Therapeutic or Diagnostic Output Failure 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Separation Failure 2 2
Product Quality Problem 2 2
Output Problem 2 2
Entrapment of Device 2 3
Improper Chemical Reaction 2 2
Device Ingredient or Reagent Problem 2 2
Failure to Obtain Sample 1 1
Defective Component 1 1
Material Too Rigid or Stiff 1 1
Component Missing 1 1
Particulates 1 1
Moisture or Humidity Problem 1 1
Device Markings/Labelling Problem 1 1
Activation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 361 361
Unspecified Infection 103 103
Skin Inflammation/ Irritation 80 80
Hypersensitivity/Allergic reaction 75 75
Bacterial Infection 64 64
Blister 60 61
Itching Sensation 50 50
Impaired Healing 37 37
Insufficient Information 37 46
Erythema 36 36
Rash 33 33
Pain 32 32
Contact Dermatitis 23 23
Swelling/ Edema 23 23
Hemorrhage/Bleeding 23 23
Post Operative Wound Infection 19 19
Fever 18 18
Burn(s) 17 17
Urinary Tract Infection 17 17
Sepsis 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Fluid Discharge 15 15
Local Reaction 15 15
Tissue Breakdown 14 14
Skin Tears 13 13
Skin Discoloration 12 12
Unspecified Tissue Injury 12 12
Purulent Discharge 12 12
Anaphylactic Shock 12 12
Burning Sensation 11 11
Post Traumatic Wound Infection 11 11
Skin Infection 11 11
Low Blood Pressure/ Hypotension 11 11
Inflammation 10 10
Skin Burning Sensation 9 9
Wound Dehiscence 9 9
Necrosis 8 8
Drug Resistant Bacterial Infection 8 8
Seroma 8 8
Hematoma 7 7
Septic Shock 7 7
Discomfort 7 7
Foreign Body In Patient 7 7
Localized Skin Lesion 6 6
Scar Tissue 6 6
Caustic/Chemical Burns 6 6
Cellulitis 6 6
Nausea 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 Integra LifeSciences Corp. II Feb-12-2025
6 Integra LifeSciences Corp. II Oct-10-2024
7 Integra LifeSciences Corp. (NeuroSciences) II Feb-13-2026
8 Integra LifeSciences Corp. (NeuroSciences) II Sep-03-2025
9 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
10 MEDLINE INDUSTRIES, LP - Northfield II Jun-21-2023
11 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
12 Medline Industries, LP II Feb-20-2026
13 Nurse Assist, LLC I Dec-20-2023
14 Z-Medica, LLC II Nov-05-2021
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