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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device components, exercise
Product CodeIOD
Regulation Number 890.5350
Device Class 1

MDR Year MDR Reports MDR Events
2018 15 15
2019 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 3 3
Patient-Device Incompatibility 2 2
Device Operates Differently Than Expected 2 2
Battery Problem 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Fracture 1 1
Product Quality Problem 1 1
Use of Device Problem 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 6
Weight Changes 4 4
No Code Available 3 3
Bruise/Contusion 3 3
Cellulitis 3 3
Menstrual Irregularities 2 2
Miscarriage 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Chest Pain 1 1
Cyst(s) 1 1
Ecchymosis 1 1
Inflammation 1 1
Irritation 1 1
Swelling 1 1
Tachycardia 1 1
Tissue Damage 1 1
Weakness 1 1
Anxiety 1 1
Toxicity 1 1
Fracture, Arm 1 1
Ambulation Difficulties 1 1

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