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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heater, perineal, radiant, non-contact
Product CodeHHA
Regulation Number 884.5390
Device Class 2

MDR Year MDR Reports MDR Events
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 1 1
Hemorrhage/Bleeding 1 1
Muscle Spasm(s) 1 1
Pain 1 1
Skin Irritation 1 1
Vertigo 1 1
Blurred Vision 1 1
Cramp(s) 1 1
Arthralgia 1 1
Abdominal Distention 1 1
Weight Changes 1 1

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