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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device barrier, absorbable, adhesion
Product CodeMCN
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
7 7 8 7 4 2

MDR Year MDR Reports MDR Events
2019 55 55
2020 44 44
2021 42 42
2022 53 53
2023 45 45
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 215 215
Patient-Device Incompatibility 7 7
Improper or Incorrect Procedure or Method 3 3
Delivered as Unsterile Product 3 3
Unexpected Therapeutic Results 3 3
Tear, Rip or Hole in Device Packaging 2 2
Device Contaminated During Manufacture or Shipping 2 2
Appropriate Term/Code Not Available 2 2
Physical Resistance/Sticking 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Device 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Contamination with Chemical or Other Material 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
Leak/Splash 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 60 60
Adhesion(s) 46 46
Abscess 45 45
Obstruction/Occlusion 37 37
Fever 30 30
Pain 30 30
Inflammation 27 27
Not Applicable 20 20
No Code Available 19 19
Peritonitis 16 16
Abdominal Pain 14 14
Hypersensitivity/Allergic reaction 9 9
No Clinical Signs, Symptoms or Conditions 9 9
Insufficient Information 8 8
Injury 8 8
Fluid Discharge 7 7
Vomiting 7 7
Bacterial Infection 7 7
Purulent Discharge 7 7
Hemorrhage/Bleeding 6 6
Wound Dehiscence 5 5
Unspecified Tissue Injury 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Edema 4 4
Foreign Body Reaction 4 4
Post Operative Wound Infection 4 4
No Consequences Or Impact To Patient 4 4
Rash 4 4
Foreign Body In Patient 3 3
Blood Loss 3 3
Headache 3 3
Fistula 3 3
Nausea 3 3
Emotional Changes 3 3
Erythema 3 3
Swelling/ Edema 3 3
Death 2 2
Failure to Anastomose 2 2
Pneumonia 2 2
Hematoma 2 2
Abdominal Distention 2 2
No Patient Involvement 2 2
Vascular System (Circulation), Impaired 2 2
Discomfort 2 2
Reaction 2 2
Scar Tissue 2 2
Sepsis 2 2
Seroma 2 2
Urticaria 2 2
Anxiety 1 1
Distress 1 1
Stenosis 1 1
Therapeutic Response, Decreased 1 1
Hernia 1 1
Cramp(s) 1 1
Dizziness 1 1
Skin Irritation 1 1
Tachycardia 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Uterine Perforation 1 1
Vertigo 1 1
Septic Shock 1 1
Local Reaction 1 1
Numbness 1 1
Coma 1 1
Deformity/ Disfigurement 1 1
Impaired Healing 1 1
Meningitis 1 1
Ascites 1 1
Patient Problem/Medical Problem 1 1
Failure of Implant 1 1
Hearing Loss 1 1
Pulmonary Edema 1 1
Necrosis 1 1
Irritation 1 1
Itching Sensation 1 1
Menstrual Irregularities 1 1
Miscarriage 1 1
Abortion 1 1
Calcium Deposits/Calcification 1 1
Cardiopulmonary Arrest 1 1
Cyst(s) 1 1
Diarrhea 1 1
Anaphylactic Shock 1 1
Aspiration/Inhalation 1 1
Fatigue 1 1
Asphyxia 1 1
Decreased Appetite 1 1
Cancer 1 1
Syncope/Fainting 1 1
Spontaneous Abortion 1 1
Drug Resistant Bacterial Infection 1 1

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