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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device components, exercise
Regulation Description Exercise component.
Product CodeIOD
Regulation Number 890.5350
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 144 144
2018 15 15
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 55 55
Insufficient Information 37 37
Device Operates Differently Than Expected 30 30
Patient-Device Incompatibility 26 26
Appropriate Term/Code Not Available 4 4
Material Integrity Problem 3 3
Unexpected Therapeutic Results 3 3
Labelling, Instructions for Use or Training Problem 2 2
Use of Device Problem 1 1
Defective Device 1 1
Break 1 1
Fracture 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Improper or Incorrect Procedure or Method 1 1
Device Unsafe to Use in Environment 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Weight Changes 56 56
Pain 48 48
Bruise/Contusion 36 36
No Code Available 32 32
Fatigue 27 27
Depression 20 20
Inflammation 19 19
Headache 17 17
Menstrual Irregularities 16 16
Swelling 15 15
Anxiety 15 15
Nausea 14 14
Complaint, Ill-Defined 13 13
Cellulitis 12 12
Tissue Damage 9 9
Dizziness 8 8
Emotional Changes 8 8
Lethargy 7 7
Heavier Menses 6 6
Rash 6 6
Thyroid Problems 6 6
Diarrhea 6 6
Arthralgia 6 6
Inadequate Pain Relief 6 6
Tissue Breakdown 5 5
Abdominal Distention 5 5
Ambulation Difficulties 5 5
Sleep Dysfunction 5 5
Palpitations 4 4
Vertigo 4 4
Malaise 4 4
Cyst(s) 4 4
Reaction 4 4
Irritability 4 4
Injury 4 4
Therapeutic Response, Decreased 4 4
Vomiting 4 4
Weakness 4 4
Hemorrhage/Bleeding 3 3
Itching Sensation 3 3
Miscarriage 3 3
Test Result 3 3
Confusion/ Disorientation 3 3
Memory Loss/Impairment 3 3
Toxicity 3 3
Skin Discoloration 3 3
Skin Irritation 3 3
Thrombus 3 3
Abdominal Cramps 3 3
Skin Inflammation 3 3
Sweating 3 3
Numbness 2 2
Thrombosis 2 2
Cramp(s) 2 2
Anemia 2 2
Autoimmune Disorder 2 2
Erythema 2 2
Vascular System (Circulation), Impaired 2 2
Blood Loss 2 2
Visual Impairment 2 2
Ptosis 2 2
Hair Loss 2 2
Nerve Damage 2 2
Scarring 2 2
Ecchymosis 2 2
Abdominal Pain 2 2
Chest Pain 2 2
Burning Sensation 2 2
Hot Flashes/Flushes 2 2
Discomfort 2 2
Myalgia 2 2
Tinnitus 1 1
Urticaria 1 1
Tingling 1 1
Urinary Tract Infection 1 1
Virus 1 1
Blurred Vision 1 1
Stroke/CVA 1 1
Edema 1 1
Unspecified Infection 1 1
Tachycardia 1 1
Undesired Nerve Stimulation 1 1
Laceration(s) 1 1
Mitral Valve Prolapse 1 1
Wrinkling 1 1
Fibrosis 1 1
No Information 1 1
Fainting 1 1
Fall 1 1
Flatus 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Irritation 1 1
Muscle Weakness 1 1
Neuropathy 1 1
Rupture 1 1
Visual Disturbances 1 1
Fracture, Arm 1 1
Deformity/ Disfigurement 1 1
Therapeutic Effects, Unexpected 1 1

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