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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
2016 1 1
2017 3 3
2018 3 3
2019 5 5
2020 13 13
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Insufficient Information 3 3
Fire 2 2
Patient-Device Incompatibility 2 2
Difficult to Open or Remove Packaging Material 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Delivered as Unsterile Product 1 1
Device Markings/Labelling Problem 1 1
Flare or Flash 1 1
Device Contamination with Chemical or Other Material 1 1

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

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