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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nursing pad, hydrogel
Product CodeNTC
Regulation Number 880.5630
Device Class 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 3 3
Adverse Event Without Identified Device or Use Problem 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Rash 3 3
Erythema 3 3
Hypersensitivity/Allergic reaction 2 2
Itching Sensation 2 2
Burning Sensation 2 2
Reaction 2 2
Urticaria 1 1
Swelling 1 1
Caustic/Chemical Burns 1 1
Inadequate Pain Relief 1 1

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