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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gown, examination
Product CodeFME
Regulation Number 880.6265
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Asphyxia 1 1
Partial thickness (Second Degree) Burn 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encompass Group LLC II Mar-22-2010
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