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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pack, heat, moist
Product CodeIMA
Regulation Number 890.5730
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2024 2 2

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 1 1
Skin Irritation 1 1
Burning Sensation 1 1
Full thickness (Third Degree) Burn 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bruder Healthcare Company, LLC II Mar-22-2024
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