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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device patient examination glove
Product CodeFMC
Regulation Number 880.6250
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 1 1
Device Emits Odor 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Reaction 2 2
Insufficient Information 2 2
Chemical Exposure 1 1
Exposure to Body Fluids 1 1
Skin Discoloration 1 1
Swelling 1 1

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