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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device solvent, adhesive tape
Product CodeKOX
Regulation Number 878.4730
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 13 13
2021 7 7
2022 3 3
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18 18
Insufficient Information 2 2
Flare or Flash 2 2
Device Emits Odor 2 2
Fire 2 2
Patient-Device Incompatibility 2 2
Device Markings/Labelling Problem 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Electrical /Electronic Property Problem 1 1
Unexpected Color 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 8 8
Pain 5 5
Skin Inflammation 5 5
Blood Loss 4 4
Rash 4 4
Increased Sensitivity 4 4
Skin Irritation 3 3
Superficial (First Degree) Burn 3 3
Skin Inflammation/ Irritation 3 3
Caustic/Chemical Burns 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Hypersensitivity/Allergic reaction 2 2
Irritation 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Dyspnea 1 1
Erythema 1 1
Headache 1 1
Fungal Infection 1 1
Tissue Breakdown 1 1
Burn, Thermal 1 1
Unspecified Tissue Injury 1 1
No Known Impact Or Consequence To Patient 1 1
Blister 1 1

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