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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device elastomer, silicone, for scar management
Regulation Description Silicone sheeting.
Product CodeMDA
Regulation Number 878.4025
Device Class 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 2 2
2019 5 5
2020 4 4
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 4 4
Loss of or Failure to Bond 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 4 4
Rash 3 3
Hypersensitivity/Allergic reaction 2 2
No Code Available 2 2
Purulent Discharge 2 2
Erythema 1 1
Foreign Body Reaction 1 1
Burn(s) 1 1
Blister 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Reaction 1 1
Numbness 1 1
Tissue Breakdown 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Infection 1 1
Itching Sensation 1 1
Nerve Damage 1 1
Pain 1 1
Skin Discoloration 1 1
Swelling 1 1
Tissue Damage 1 1
Toxic Shock Syndrome 1 1
Burning Sensation 1 1
Ulcer 1 1

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