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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device massager, therapeutic, manual
Regulation Description Therapeutic massager.
Product CodeLYG
Regulation Number 890.5660
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 1 1
2019 4 4
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Inappropriate/Inadequate Shock/Stimulation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Scratched Material 1 1
Break 1 1
Patient-Device Incompatibility 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Insufficient Information 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Weight Changes 2 2
No Code Available 1 1
Abdominal Pain 1 1
Bruise/Contusion 1 1
Chest Pain 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Nausea 1 1
Pain 1 1
Weakness 1 1
Therapeutic Response, Decreased 1 1
Anxiety 1 1
Depression 1 1
Reaction 1 1
Electric Shock 1 1
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Menstrual Irregularities 1 1
Skin Irritation 1 1
Swelling 1 1
Malaise 1 1
Numbness 1 1
Abdominal Distention 1 1
No Known Impact Or Consequence To Patient 1 1

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