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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
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 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
Off-Label Use 1 1
Migration or Expulsion of Device 1 1
Mechanical Problem 1 1
Fire 1 1
Split 1 1
Patient Device Interaction Problem 1 1
Scratched Material 1 1
Material Twisted/Bent 1 1
Gas/Air Leak 1 1
Misassembly by Users 1 1
Use of Incorrect Control/Treatment Settings 1 1
Stretched 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Structural Problem 1 1
Device Emits Odor 1 1
Material Separation 1 1
Unintended Movement 1 1
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Defective Component 1 1
Naturally Worn 1 1
Gel Leak 1 1
Unintended System Motion 1 1
Loose or Intermittent Connection 1 1
Detachment Of Device Component 1 1
Fluid/Blood Leak 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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