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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device strap, head, gas mask
Product CodeBTK
Regulation Number 868.5560
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 1 1
Peeled/Delaminated 1 1
Material Rupture 1 1
Defective Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2

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