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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tamp
Product CodeHXG
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 2 2
2017 7 7
2018 7 7
2019 15 15
2020 8 8
2021 7 7
2022 5 5
2023 4 4
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 26 26
Break 19 19
Crack 7 7
Leak/Splash 5 5
Device-Device Incompatibility 4 4
Material Deformation 4 4
Fracture 4 4
Naturally Worn 2 2
Fluid/Blood Leak 2 2
Difficult to Remove 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 2
Inflation Problem 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
No Clinical Signs, Symptoms or Conditions 22 22
No Consequences Or Impact To Patient 5 5
No Information 3 3
Bone Fracture(s) 3 3
Insufficient Information 3 3
Foreign Body In Patient 2 2
Extravasation 2 2
Hematoma 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Device Embedded In Tissue or Plaque 1 1

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