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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bandage, liquid
Regulation Description Liquid bandage.
Product CodeKMF
Regulation Number 880.5090
Device Class 1


Premarket Reviews
ManufacturerDecision
OPTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 10 10
2022 7 7
2023 6 6
2024 6 6
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Improper or Incorrect Procedure or Method 7 7
Appropriate Term/Code Not Available 4 4
Compatibility Problem 2 2
Patient Device Interaction Problem 2 2
Device-Device Incompatibility 1 1
Off-Label Use 1 1
Difficult to Open or Remove Packaging Material 1 1
Inadequate Lubrication 1 1
Insufficient Information 1 1
Defective Component 1 1
Contamination /Decontamination Problem 1 1
Improper Flow or Infusion 1 1
Delivered as Unsterile Product 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Skin Inflammation/ Irritation 7 7
Rash 6 6
Hypersensitivity/Allergic reaction 5 5
Blister 3 3
Erythema 3 3
Insufficient Information 3 3
Unspecified Infection 2 2
Superficial (First Degree) Burn 2 2
Not Applicable 2 2
Burn(s) 2 2
Contact Dermatitis 2 2
Swelling/ Edema 2 2
Hemorrhage/Bleeding 2 2
No Consequences Or Impact To Patient 2 2
Skin Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sepsis 1 1
Fungal Infection 1 1
Anaphylactoid 1 1
Skin Discoloration 1 1
No Known Impact Or Consequence To Patient 1 1
Pain 1 1
Coma 1 1
Fluid Discharge 1 1
Skin Tears 1 1
Caustic/Chemical Burns 1 1
Full thickness (Third Degree) Burn 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Mar-09-2020
2 Family Dollar Stores, Llc. II Aug-17-2022
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