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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
2014 6 6
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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
Degraded 16 16
Deformation Due to Compressive Stress 16 16
Adverse Event Without Identified Device or Use Problem 12 12
Crack 7 7
Burst Container or Vessel 7 7
Use of Device Problem 3 3
Appropriate Term/Code Not Available 3 3
Device Operates Differently Than Expected 3 3
Material Integrity Problem 2 2
Device Slipped 2 2
Insufficient Information 2 2
Patient Device Interaction Problem 1 1
Positioning Problem 1 1
Scratched Material 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Stretched 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Gas/Air Leak 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 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
Gel 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 30 30
No Known Impact Or Consequence To Patient 21 21
No Clinical Signs, Symptoms or Conditions 21 21
No Information 7 7
No Consequences Or Impact To Patient 3 3
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
Burn(s) 1 1
Injury 1 1
No Code Available 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bock,Otto,Orthopedic Ind,Inc II Mar-21-2014
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