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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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
Deformation Due to Compressive Stress 16 16
Degraded 16 16
Adverse Event Without Identified Device or Use Problem 12 12
Crack 7 7
Burst Container or Vessel 7 7
Appropriate Term/Code Not Available 4 4
Use of Device Problem 3 3
Device Operates Differently Than Expected 3 3
Device Slipped 2 2
Insufficient Information 2 2
Material Integrity Problem 2 2
Split 1 1
Scratched Material 1 1
Patient Device Interaction Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Misassembly by Users 1 1
Detachment Of Device Component 1 1
Fluid/Blood Leak 1 1
Material Separation 1 1
Device Emits Odor 1 1
Gel Leak 1 1
Naturally Worn 1 1
Unintended System Motion 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Fire 1 1
Off-Label Use 1 1
Mechanical Problem 1 1
Unintended Movement 1 1
Patient-Device Incompatibility 1 1
Positioning Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Stretched 1 1
Material Twisted/Bent 1 1
Gas/Air Leak 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 30 30
No Clinical Signs, Symptoms or Conditions 21 21
No Known Impact Or Consequence To Patient 21 21
No Information 7 7
No Consequences Or Impact To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hip Fracture 2 2
Fall 2 2
Respiratory Distress 1 1
No Code Available 1 1
Head Injury 1 1
Abrasion 1 1
Local Reaction 1 1
Burn(s) 1 1
Skin Erosion 1 1
Injury 1 1
Insufficient Information 1 1
Laceration(s) 1 1
Pain 1 1
Skin Tears 1 1
Hemorrhage/Bleeding 1 1
Full thickness (Third Degree) Burn 1 1

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