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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cultured human cell skin dressing
Definition Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers.
Product CodePFC
Device Class 3

MDR Year MDR Reports MDR Events
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 1 1
Local Reaction 1 1
Erythema 1 1
Swelling/ Edema 1 1
Granuloma 1 1

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