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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device bandage, liquid, skin protectant
Product CodeNEC
Regulation Number 880.5090
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 5 5
2021 7 7
2022 5 5
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Patient Device Interaction Problem 5 5
Off-Label Use 3 3
Device Handling Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Flare or Flash 1 1
Loss of or Failure to Bond 1 1
Fire 1 1
Leak/Splash 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Skin Inflammation/ Irritation 4 4
Wound Dehiscence 4 4
Burn(s) 3 3
Rash 2 2
Local Reaction 1 1
Skin Irritation 1 1
Urinary Tract Infection 1 1
Vomiting 1 1
Discomfort 1 1
Reaction 1 1
Skin Tears 1 1
Caustic/Chemical Burns 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
Cough 1 1
Blister 1 1
Skin Burning Sensation 1 1
Erythema 1 1
Unspecified Infection 1 1
Itching Sensation 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1

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