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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bandage, liquid, skin protectant
Regulation Description Liquid bandage.
Product CodeNEC
Regulation Number 880.5090
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 2 2
2019 1 1
2020 5 5
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Therapeutic or Diagnostic Output Failure 2 2
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Loss of or Failure to Bond 1 1
Leak/Splash 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Device Damaged Prior to Use 1 1
Patient-Device Incompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Rash 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Skin Irritation 2 2
Swelling 2 2
Burn(s) 2 2
Discomfort 2 2
Impaired Healing 1 1
Reaction 1 1
Fungal Infection 1 1
Skin Tears 1 1
Caustic/Chemical Burns 1 1
No Patient Involvement 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
No Known Impact Or Consequence To Patient 1 1
Partial thickness (Second Degree) Burn 1 1
Insufficient Information 1 1
Erythema 1 1
Pain 1 1
Local Reaction 1 1
Skin Discoloration 1 1
Urinary Tract Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES INC II Oct-06-2018
2 Safe N Simple, LLC II Jun-29-2018
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