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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device device, gas generating
Product CodeKZJ
Regulation Number 866.2580
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2019 1 1
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Defective Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Markings/Labelling Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Laceration(s) 2 2
Injury 1 1
Insufficient Information 1 1

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