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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device armrest, wheelchair
Product CodeIML
Regulation Number 890.3920
Device Class 1

MDR Year MDR Reports MDR Events
2014 12 12
2015 4 4
2018 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Bent 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Crack 1 1
Material Separation 1 1
Device Slipped 1 1
Sticking 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Out-Of-Box Failure 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11 11
No Information 5 5
Fall 2 2
Bone Fracture(s) 1 1
Laceration(s) 1 1
Pain 1 1
Hip Fracture 1 1

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