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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, erythrocyte sedimentation rate
Product CodeJPH
Regulation Number 864.6700
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 1 1
2018 2 2
2019 2 2
2020 4 4
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Material Integrity Problem 1 1
Explosion 1 1
Fluid/Blood Leak 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 3 3
Not Applicable 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Injury 1 1
Exposure to Body Fluids 1 1

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