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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cushion, wheelchair
Product CodeIMP
Regulation Number 890.3920
Device Class 1

MDR Year MDR Reports MDR Events
2015 17 17
2016 15 15
2018 2 2
2019 5 5
2020 6 6
2021 5 5
2022 11 11
2023 24 24
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 18 18
Degraded 16 16
Deformation Due to Compressive Stress 16 16
Adverse Event Without Identified Device or Use Problem 12 12
Burst Container or Vessel 7 7
Crack 6 6
Appropriate Term/Code Not Available 4 4
Use of Device Problem 3 3
Insufficient Information 2 2
Material Integrity Problem 2 2
Device Operates Differently Than Expected 2 2
Gas/Air Leak 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Scratched Material 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Patient Device Interaction Problem 1 1
Structural Problem 1 1
Split 1 1
Patient-Device Incompatibility 1 1
Detachment Of Device Component 1 1
Use of Incorrect Control/Treatment Settings 1 1
Fire 1 1
Fluid/Blood Leak 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Device Emits Odor 1 1
Unintended System Motion 1 1
Off-Label Use 1 1
Material Separation 1 1
Device Slipped 1 1
Stretched 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 29 29
No Clinical Signs, Symptoms or Conditions 21 21
No Known Impact Or Consequence To Patient 17 17
No Information 7 7
No Consequences Or Impact To Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hip Fracture 2 2
Fall 2 2
Head Injury 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Pain 1 1
Local Reaction 1 1
Respiratory Distress 1 1
Skin Erosion 1 1
Skin Tears 1 1
Full thickness (Third Degree) Burn 1 1
Injury 1 1
Abrasion 1 1
Burn(s) 1 1
No Code Available 1 1

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