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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 DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
IMBED BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 1
INFECTION ELIMINATION SOLUTIONS, LLC
  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
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 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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 284 284
Adverse Event Without Identified Device or Use Problem 190 190
Contamination /Decontamination Problem 175 175
Device Contaminated During Manufacture or Shipping 108 108
Unsealed Device Packaging 90 90
Contamination 88 88
Insufficient Information 63 63
Packaging Problem 56 56
Patient-Device Incompatibility 40 41
Patient Device Interaction Problem 39 39
Appropriate Term/Code Not Available 28 28
Device Damaged Prior to Use 27 27
Difficult to Remove 25 25
Improper or Incorrect Procedure or Method 11 11
No Apparent Adverse Event 10 10
Nonstandard Device 8 8
Device Contamination with Chemical or Other Material 7 7
Off-Label Use 7 7
Biocompatibility 6 6
Loss of or Failure to Bond 6 15
Use of Device Problem 6 6
Physical Resistance/Sticking 5 5
Lack of Effect 5 5
Material Disintegration 5 5
Device Appears to Trigger Rejection 4 4
Device Handling Problem 4 4
Material Fragmentation 3 3
Fluid/Blood Leak 3 3
Material Discolored 3 3
Material Integrity Problem 3 3
Break 3 3
Entrapment of Device 2 3
Product Quality Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Improper Chemical Reaction 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Ingredient or Reagent Problem 2 2
Separation Failure 2 2
Material Separation 1 1
Adhesive Too Strong 1 1
Defective Component 1 1
Illegible Information 1 1
Activation Problem 1 1
Component Missing 1 1
Fungus in Device Environment 1 1
Failure to Infuse 1 1
Material Split, Cut or Torn 1 1
Output Problem 1 1
Moisture or Humidity Problem 1 1
Increase in Pressure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 359 359
Unspecified Infection 80 80
Skin Inflammation/ Irritation 80 80
Hypersensitivity/Allergic reaction 71 71
Bacterial Infection 62 62
Blister 54 55
Itching Sensation 49 49
Insufficient Information 36 45
Erythema 35 35
Rash 33 33
Impaired Healing 28 28
Pain 28 28
Contact Dermatitis 23 23
Hemorrhage/Bleeding 23 23
Swelling/ Edema 21 21
Fever 18 18
Urinary Tract Infection 17 17
Post Operative Wound Infection 17 17
Sepsis 16 16
Local Reaction 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Burn(s) 13 13
Skin Tears 13 13
Fluid Discharge 13 13
Tissue Breakdown 13 13
Skin Discoloration 12 12
Unspecified Tissue Injury 12 12
Anaphylactic Shock 12 12
Skin Infection 11 11
Low Blood Pressure/ Hypotension 11 11
Inflammation 10 10
Purulent Discharge 10 10
Skin Burning Sensation 9 9
Post Traumatic Wound Infection 9 9
Seroma 8 8
Burning Sensation 8 8
Drug Resistant Bacterial Infection 8 8
Wound Dehiscence 8 8
Necrosis 8 8
Hematoma 7 7
Septic Shock 7 7
Discomfort 7 7
Foreign Body In Patient 7 7
Localized Skin Lesion 6 6
Skin Erosion 6 6
Joint Dislocation 5 5
Muscle Weakness 5 5
Loss of Range of Motion 5 5
Caustic/Chemical Burns 5 5
Deformity/ Disfigurement 4 4

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 Nurse Assist, LLC I Dec-20-2023
13 Z-Medica, LLC II Nov-05-2021
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