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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device trousers, anti-shock
Regulation Description Compressible limb sleeve.
Product CodeLHX
Regulation Number 870.5800
Device Class 2

MDR Year MDR Reports MDR Events
2016 2 2
2017 5 5
2018 10 10
2019 26 26
2020 2 2
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 28 28
Loose or Intermittent Connection 6 6
Device Damaged Prior to Use 4 4
Component Missing 4 4
Fracture 3 3
Naturally Worn 2 2
Material Deformation 2 2
Positioning Failure 1 1
Crack 1 1
Mechanical Problem 1 1
Scratched Material 1 1
Difficult to Insert 1 1
Difficult to Remove 1 1
Patient-Device Incompatibility 1 1
Device Inoperable 1 1
Failure to Advance 1 1
Compatibility Problem 1 1
Appropriate Term/Code Not Available 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 36 36
No Clinical Signs, Symptoms or Conditions 5 5
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
No Code Available 1 1
Injury 1 1
Bone Fracture(s) 1 1
Pain 1 1

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