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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trousers, anti-shock
Product CodeLHX
Regulation Number 870.5800
Device Class 2

MDR Year MDR Reports MDR Events
2017 5 5
2018 10 10
2019 26 26
2020 2 2
2021 5 5
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 31 31
Loose or Intermittent Connection 6 6
Device Damaged Prior to Use 4 4
Component Missing 4 4
Fracture 3 3
Material Deformation 2 2
Naturally Worn 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Scratched Material 1 1
Failure to Advance 1 1
Patient-Device Incompatibility 1 1
Compatibility Problem 1 1
Difficult to Insert 1 1
Crack 1 1
Positioning Failure 1 1
Mechanical Problem 1 1
Difficult to Remove 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 35 35
No Clinical Signs, Symptoms or Conditions 7 7
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
No Code Available 1 1
Foreign Body In Patient 1 1
Injury 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1

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