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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sling, overhead suspension, wheelchair
Product CodeINE
Regulation Number 890.3910
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 9 9
2016 6 6
2017 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Frayed 5 5
Break 4 4
Torn Material 2 2
Material Separation 2 2
Detachment of Device or Device Component 1 1
Crack 1 1
Component Falling 1 1
Unraveled Material 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Split, Cut or Torn 1 1
Use of Device Problem 1 1
Degraded 1 1
Tear, Rip or Hole in Device Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Fracture 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 9 9
Death 2 2
Laceration(s) 2 2
No Consequences Or Impact To Patient 2 2
Fall 1 1
Head Injury 1 1
No Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Contusion 1 1

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