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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
2019 5 5
2020 6 6
2021 5 5
2022 11 11
2023 24 24
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 16 16
Deformation Due to Compressive Stress 16 16
Adverse Event Without Identified Device or Use Problem 11 11
Burst Container or Vessel 6 6
Appropriate Term/Code Not Available 4 4
Insufficient Information 2 2
Use of Device Problem 2 2
Off-Label Use 1 1
Stretched 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Misassembly by Users 1 1
Use of Incorrect Control/Treatment Settings 1 1
Loose or Intermittent Connection 1 1
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Patient Device Interaction Problem 1 1
Unintended System Motion 1 1
Naturally Worn 1 1
Gas/Air Leak 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 27 27
No Clinical Signs, Symptoms or Conditions 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hip Fracture 1 1
Respiratory Distress 1 1
Local Reaction 1 1
Abrasion 1 1
Skin Erosion 1 1
Burn(s) 1 1
Insufficient Information 1 1
Fall 1 1
Hemorrhage/Bleeding 1 1
Full thickness (Third Degree) Burn 1 1

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