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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device elevator
Product CodeHTE
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 7 7
2019 11 11
2020 12 12
2021 3 3
2022 12 12
2023 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 36 36
Contamination /Decontamination Problem 9 9
Crack 3 3
Material Discolored 2 2
Device Operates Differently Than Expected 2 2
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Material Fragmentation 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
No Consequences Or Impact To Patient 16 16
No Patient Involvement 8 8
No Known Impact Or Consequence To Patient 2 2
No Code Available 2 2
Injury 1 1
Pain 1 1
Swelling 1 1

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