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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
Regulation Description Surgical skin degreaser or adhesive tape solvent.
Product CodeKOX
Regulation Number 878.4730
Device Class 1

MDR Year MDR Reports MDR Events
2020 15 15
2021 7 7
2022 3 3
2023 3 3
2025 1 1

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

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

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