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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 dressing, wound and burn, occlusive
Product CodeMGP
Device Class Unclassified

MDR Year MDR Reports MDR Events
2021 52 52
2022 3 3
2023 4 4
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 60 60
Entrapment of Device 2 2
Difficult to Remove 1 1
Use of Device Problem 1 1
Material Integrity Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 21 21
Impaired Healing 20 20
Skin Disorders 10 10
Localized Skin Lesion 8 8
Bacterial Infection 7 7
Skin Infection 6 6
Tissue Breakdown 4 4
Skin Erosion 3 3
Pain 3 3
Insufficient Information 3 3
Drug Resistant Bacterial Infection 2 2
Ulcer 2 2
Hypersensitivity/Allergic reaction 2 2
Device Embedded In Tissue or Plaque 2 2
Post Operative Wound Infection 1 1
Toxic Shock Syndrome 1 1
Itching Sensation 1 1
Anaphylactic Shock 1 1
Erythema 1 1
Peeling 1 1
Scar Tissue 1 1
Skin Discoloration 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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