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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device shoe, cast
Product CodeIPG
Regulation Number 890.3025
Device Class 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 2 2
2016 5 5
2017 2 2
2018 1 1
2019 3 3
2020 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Patient Device Interaction Problem 5 5
Device Operates Differently Than Expected 2 2
Incorrect Device Or Component Shipped 1 1
Naturally Worn 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Bent 1 1
Break 1 1
Pocket Stimulation 1 1
Component Missing 1 1
Patient-Device Incompatibility 1 1
Communication or Transmission Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 5 5
Skin Inflammation/ Irritation 5 5
Post Operative Wound Infection 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
Missing Value Reason 1 1
Wound Dehiscence 1 1
Cellulitis 1 1
Bone Fracture(s) 1 1
Unspecified Infection 1 1
Nerve Damage 1 1
Tissue Damage 1 1
Discomfort 1 1
Impaired Healing 1 1

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