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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
2019 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 3 3
Cellulitis 1 1

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