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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
CONNEXICON MEDICAL LTD.
  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 196 196

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 875 875
Patient-Device Incompatibility 20 20
Appropriate Term/Code Not Available 14 14
Delivered as Unsterile Product 13 13
Device Markings/Labelling Problem 8 8
Material Separation 8 8
Loss of or Failure to Bond 6 6
Patient Device Interaction Problem 5 5
Device Contaminated During Manufacture or Shipping 3 3
Contamination /Decontamination Problem 3 3
Material Integrity Problem 2 2
Use of Device Problem 2 2
Biocompatibility 2 2
Chemical Problem 1 1
Off-Label Use 1 1
Peeled/Delaminated 1 1
Insufficient Information 1 1
Stretched 1 1
Lack of Effect 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 256 256
Rash 190 190
Itching Sensation 168 168
Hypersensitivity/Allergic reaction 157 157
Blister 138 138
Unspecified Infection 125 125
Erythema 120 120
Wound Dehiscence 115 115
Local Reaction 106 106
Skin Irritation 100 100
Inflammation 82 82
Tissue Damage 54 54
Not Applicable 44 44
Burning Sensation 38 38
Impaired Healing 28 28
No Clinical Signs, Symptoms or Conditions 28 28
Fluid Discharge 27 27
Skin Discoloration 21 21
Pain 21 21
Necrosis 20 20
Burn(s) 18 18
Swelling/ Edema 17 17
Reaction 15 15
Post Operative Wound Infection 13 13
Insufficient Information 13 13
Scar Tissue 13 13
Cellulitis 12 12
Hematoma 11 11
Seroma 10 10
Discomfort 10 10
Swelling 10 10
No Code Available 9 9
Purulent Discharge 9 9
Hemorrhage/Bleeding 8 8
No Consequences Or Impact To Patient 6 6
Urticaria 6 6
Abscess 4 4
Chills 3 3
Unspecified Tissue Injury 3 3
Contact Dermatitis 3 3
Skin Disorders 2 2
No Known Impact Or Consequence To Patient 2 2
Partial thickness (Second Degree) Burn 2 2
Caustic/Chemical Burns 2 2
Anxiety 2 2
Skin Inflammation 2 2
Bacterial Infection 2 2
Bruise/Contusion 2 2
Emotional Changes 2 2
Fatigue 2 2

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