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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transilluminator, battery-powered
Product CodeHJN
Regulation Number 886.1945
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2018 1 1
2020 1 1
2022 2 2
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Melted 1 1
Device Issue 1 1
Component or Accessory Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Temperature Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 3 3
Full thickness (Third Degree) Burn 2 2
Blister 2 2
Abrasion 1 1
Skin Discoloration 1 1
Skin Erosion 1 1
Skin Irritation 1 1
Injury 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1

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