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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
2018 7 7
2019 15 15
2020 8 8
2021 7 7
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 22 22
Break 9 9
Leak/Splash 5 5
Fluid/Blood Leak 2 2
Naturally Worn 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 1 1
Device-Device Incompatibility 1 1
Inflation Problem 1 1
Burst Container or Vessel 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 20 20
No Clinical Signs, Symptoms or Conditions 10 10
No Consequences Or Impact To Patient 5 5
Extravasation 2 2
Bone Fracture(s) 1 1
Hematoma 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Insufficient Information 1 1

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