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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adhesive, denture, carboxymethylcellulose sodium (32%) and ethylene-oxide homopolymer
Product CodeKOL
Regulation Number 872.3410
Device Class 1

MDR Year MDR Reports MDR Events
2014 30 30
2015 47 47
2016 1 1
2017 3 3
2018 2 2
2019 3 3
2020 5 5
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 25 25
Insufficient Information 22 22
Adverse Event Without Identified Device or Use Problem 21 21
Improper or Incorrect Procedure or Method 6 6
Loss of or Failure to Bond 5 5
Use of Device Problem 3 3
Product Quality Problem 3 3
Appropriate Term/Code Not Available 3 3
Device Operates Differently Than Expected 3 3
Human-Device Interface Problem 1 1
Material Deformation 1 1
Device Slipped 1 1
Material Disintegration 1 1
Melted 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15 15
No Code Available 15 15
Hemorrhage/Bleeding 10 10
Toxicity 10 10
Foreign Body In Patient 8 8
Death 8 8
Nausea 8 8
Ambulation Difficulties 7 7
Choking 6 6
Discomfort 6 6
Complaint, Ill-Defined 6 6
Sleep Dysfunction 5 5
Reaction 5 5
Numbness 5 5
Burning Sensation 4 4
Malaise 4 4
Headache 4 4
Overdose 4 4
Swelling 4 4
Hypersensitivity/Allergic reaction 4 4
Test Result 4 4
Seizures 3 3
Emotional Changes 3 3
Fall 3 3
Diarrhea 3 3
Neurological Deficit/Dysfunction 3 3
Unspecified Infection 3 3
Tingling 3 3
Vomiting 3 3
Dizziness 3 3
Dysphasia 3 3
Cognitive Changes 3 3
Confusion/ Disorientation 2 2
Rupture 2 2
Anaphylactoid 2 2
Tissue Damage 2 2
Disability 2 2
Neuropathy 2 2
Irritation 2 2
Ischemia 2 2
Dysphagia/ Odynophagia 2 2
Dyspnea 2 2
Abdominal Pain 2 2
Anemia 2 2
Bacterial Infection 2 2
High Blood Pressure/ Hypertension 2 2
Stroke/CVA 2 2
Bone Fracture(s) 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Information 2 2
Cancer 2 2
Unspecified Eye / Vision Problem 1 1
Fatigue 1 1
Fever 1 1
Fainting 1 1
Erosion 1 1
Asthma 1 1
Dementia 1 1
Itching Sensation 1 1
Memory Loss/Impairment 1 1
Inflammation 1 1
Tinnitus 1 1
Paralysis 1 1
Peeling 1 1
Rash 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Sore Throat 1 1
Injury 1 1
Jaundice 1 1
Visual Impairment 1 1
Weakness 1 1
Therapeutic Response, Decreased 1 1
Urticaria 1 1
Anxiety 1 1
Vascular System (Circulation), Impaired 1 1
Ascites 1 1
Weight Changes 1 1
Osteopenia/ Osteoporosis 1 1
Difficulty Chewing 1 1
Dysuria 1 1
Paraplegia 1 1
Abdominal Cramps 1 1
Caustic/Chemical Burns 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1

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