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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device attachment, commode, wheelchair
Product CodeINB
Regulation Number 890.3920
Device Class 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 1 1
2016 1 1
2018 1 1
2019 2 2
2020 1 1
2021 1 1
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Collapse 3 3
Loose or Intermittent Connection 2 2
Device Slipped 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
No Fail-Safe Mechanism 1 1
Protective Measures Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Fell 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 5 5
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
Bone Fracture(s) 2 2
Pain 1 1
Injury 1 1
Hip Fracture 1 1
Tooth Fracture 1 1
Skin Tears 1 1
Multiple Fractures 1 1

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