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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adhesive backed thermal skin patches
Definition Pain relief heat patches for temporary relief of muscular and joint pian assoiciated with arthritis, simple backache, muscle strains and sprains.External use only. Not on damaged skin or open sores. Do no use under the age of 12. Do use on people who are not able to feel pain. Patch is applied directly to site of pain over intact skin for up to 8 hours but not more than once in a 24 hour period. Do not use more than 7 days. Over the counter device. No prescription. Do not sleep on or put pressure on heat patch for extended period of time. Do not use with any creams or oils. Can remove body hair upon patch removal due to adhesive. Can cause burns.
Product CodeOMW
Regulation Number 890.5710
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2023 2 2
2024 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Swelling 1 1
Tachycardia 1 1
Tinnitus 1 1
Blurred Vision 1 1
Chills 1 1
Dizziness 1 1
Sleep Dysfunction 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Weight Changes 1 1
Unspecified Gastrointestinal Problem 1 1
Emotional Changes 1 1
Erythema 1 1
Headache 1 1
High Blood Pressure/ Hypertension 1 1

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