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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
Regulation Description Tissue adhesive with adjunct wound closure device for topical approximation of skin.
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
CHEMENCE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ETHICON, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 124 124
2017 163 163
2018 206 206
2019 153 153
2020 86 86
2021 150 150

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 390 390
Appropriate Term/Code Not Available 300 300
Patient-Device Incompatibility 69 69
Device Markings/Labelling Problem 65 65
Insufficient Information 13 13
Compatibility Problem 7 7
Tear, Rip or Hole in Device Packaging 6 6
Loss of or Failure to Bond 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Improper or Incorrect Procedure or Method 3 3
Contamination /Decontamination Problem 3 3
Incorrect Device Or Component Shipped 2 2
Leak/Splash 2 2
Unsealed Device Packaging 2 2
Failure To Adhere Or Bond 2 2
Biocompatibility 2 2
Material Separation 2 2
Stretched 1 1
Unexpected Therapeutic Results 1 1
Break 1 1
Contamination 1 1
Material Discolored 1 1
Device Expiration Issue 1 1
Material Fragmentation 1 1
Peeled/Delaminated 1 1
Component Missing 1 1
Material Integrity Problem 1 1
No Apparent Adverse Event 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 303 303
Rash 208 208
Skin Irritation 161 161
Hypersensitivity/Allergic reaction 154 154
Itching Sensation 142 142
Reaction 114 114
Local Reaction 107 107
Erythema 101 101
No Consequences Or Impact To Patient 86 86
Tissue Damage 79 79
Unspecified Infection 79 79
Inflammation 78 78
Not Applicable 78 78
Wound Dehiscence 69 69
Blister 47 47
Skin Discoloration 30 30
Pain 28 28
Necrosis 23 23
Swelling 21 21
Skin Inflammation/ Irritation 17 17
Discharge 13 13
Cellulitis 12 12
Impaired Healing 11 11
Post Operative Wound Infection 10 10
Seroma 9 9
Fluid Discharge 9 9
Burning Sensation 9 9
Irritation 9 9
Hematoma 8 8
Burn(s) 7 7
Scarring 5 5
Abscess 5 5
Purulent Discharge 5 5
Scar Tissue 4 4
Hemorrhage/Bleeding 4 4
Ischemia 4 4
No Known Impact Or Consequence To Patient 4 4
Blood Loss 4 4
Discomfort 3 3
Fever 3 3
Foreign Body Reaction 3 3
Bruise/Contusion 3 3
Cerebrospinal Fluid Leakage 2 2
Bacterial Infection 2 2
Sepsis 2 2
Nausea 2 2
Ulcer 2 2
Chills 2 2
Organ Dehiscence 2 2
Skin Inflammation 2 2
Needle Stick/Puncture 1 1
Caustic/Chemical Burns 1 1
Skin Disorders 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Dizziness 1 1
Skin Erosion 1 1
Urticaria 1 1
Hypoesthesia 1 1
Extubate 1 1
Laceration(s) 1 1
Exposure to Body Fluids 1 1
Failure to Anastomose 1 1
Granuloma 1 1
Fistula 1 1
Edema 1 1
Fatigue 1 1

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