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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device exerciser, non-measuring
Product CodeION
Regulation Number 890.5370
Device Class 1

MDR Year MDR Reports MDR Events
2019 9 9
2020 6 6
2021 7 7
2022 5 5
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 11 11
Break 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 3 3
Detachment of Device or Device Component 2 2
Use of Device Problem 2 2
Defective Component 1 1
Burst Container or Vessel 1 1
Crack 1 1
Loose or Intermittent Connection 1 1
Unintended System Motion 1 1
Device Slipped 1 1
Inadequate or Insufficient Training 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Clinical Signs, Symptoms or Conditions 7 7
Hematoma 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Laceration(s) 2 2
Fall 2 2
Bone Fracture(s) 1 1
Head Injury 1 1
Headache 1 1
Bruise/Contusion 1 1
Emotional Changes 1 1
Erythema 1 1
Eye Injury 1 1
Skin Irritation 1 1
Swelling 1 1
Injury 1 1
Loss of consciousness 1 1
Foreign Body In Patient 1 1
No Code Available 1 1
Limb Fracture 1 1
Multiple Fractures 1 1
Hemorrhage/Bleeding 1 1

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