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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device elastomer, silicone, for scar management
Product CodeMDA
Regulation Number 878.4025
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 4 4
2021 3 3
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 3 3
Biocompatibility 2 2
Patient-Device Incompatibility 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Gel Leak 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 4
Hypersensitivity/Allergic reaction 3 3
Rash 3 3
Sepsis 2 2
Blister 2 2
Local Reaction 2 2
Injury 2 2
Swelling/ Edema 2 2
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Skin Infection 1 1
Urticaria 1 1
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Skin Inflammation/ Irritation 1 1
Purulent Discharge 1 1
Itching Sensation 1 1
Foreign Body Reaction 1 1
Skin Discoloration 1 1
Burning Sensation 1 1
Burn(s) 1 1
Nerve Damage 1 1
Numbness 1 1
Erythema 1 1
Scar Tissue 1 1
Visual Impairment 1 1
Reaction 1 1
Abscess 1 1
Toxic Shock Syndrome 1 1
Contact Dermatitis 1 1
Ulcer 1 1
Skin Tears 1 1
Blurred Vision 1 1
Caustic/Chemical Burns 1 1
Tissue Breakdown 1 1

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