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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cutaneous tissue adhesive with mesh
Definition For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures.
Product CodeOMD
Regulation Number 878.4011
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED MEDICAL SOLUTIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CHEMENCE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 153 153
2020 86 86
2021 186 186
2022 175 175
2023 171 171
2024 127 127

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 825 825
Patient-Device Incompatibility 20 20
Delivered as Unsterile Product 13 13
Device Markings/Labelling Problem 8 8
Loss of or Failure to Bond 6 6
Material Separation 5 5
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 3 3
Contamination /Decontamination Problem 3 3
Material Integrity Problem 2 2
Biocompatibility 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Stretched 1 1
Fluid/Blood Leak 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Chemical Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 231 231
Rash 187 187
Itching Sensation 167 167
Hypersensitivity/Allergic reaction 132 132
Blister 128 128
Unspecified Infection 114 114
Erythema 113 113
Local Reaction 106 106
Wound Dehiscence 104 104
Skin Irritation 100 100
Inflammation 75 75
Tissue Damage 54 54
Not Applicable 44 44
Burning Sensation 36 36
Impaired Healing 28 28
No Clinical Signs, Symptoms or Conditions 25 25
Fluid Discharge 22 22
Skin Discoloration 20 20
Necrosis 19 19
Pain 19 19
Burn(s) 15 15
Reaction 15 15
Scar Tissue 13 13
Swelling/ Edema 12 12
Post Operative Wound Infection 12 12
Cellulitis 11 11
Discomfort 10 10
Swelling 10 10
Insufficient Information 9 9
No Code Available 9 9
Seroma 9 9
Hematoma 9 9
Purulent Discharge 8 8
Hemorrhage/Bleeding 6 6
No Consequences Or Impact To Patient 6 6
Urticaria 6 6
Abscess 4 4
Chills 3 3
Unspecified Tissue Injury 3 3
Skin Inflammation 2 2
No Known Impact Or Consequence To Patient 2 2
Partial thickness (Second Degree) Burn 2 2
Anxiety 2 2
Caustic/Chemical Burns 2 2
Bacterial Infection 2 2
Bruise/Contusion 2 2
Emotional Changes 2 2
Fatigue 2 2
Fistula 2 2
Nausea 2 2
Failure of Implant 1 1
Nerve Damage 1 1
Scarring 1 1
Sepsis 1 1
Granuloma 1 1
Fever 1 1
Failure to Anastomose 1 1
Fall 1 1
Pulmonary Embolism 1 1
Ecchymosis 1 1
Edema 1 1
Blood Loss 1 1
Thromboembolism 1 1
Superficial (First Degree) Burn 1 1
Hypoesthesia 1 1
Joint Dislocation 1 1
Dizziness 1 1
Hernia 1 1
Skin Disorders 1 1
Contact Dermatitis 1 1
Drug Resistant Bacterial Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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