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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dna probe, trichomonas vaginalis
Product CodeMJK
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2014 32 32
2015 7 7
2016 2 2
2018 3 3
2022 1 1
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 16 16
Device Displays Incorrect Message 7 7
Break 4 4
Failure to Charge 4 4
Unable to Obtain Readings 3 3
Battery Problem 3 3
Failure of Device to Self-Test 3 3
Naturally Worn 2 2
Noise, Audible 2 2
Failure to Power Up 2 2
Communication or Transmission Problem 2 2
Use of Device Problem 2 2
Self-Activation or Keying 2 2
Defibrillation/Stimulation Problem 1 1
Failure to Read Input Signal 1 1
Sticking 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
No Display/Image 1 1
High impedance 1 1
No Audible Prompt/Feedback 1 1
Defective Component 1 1
Failure to Calibrate 1 1
Defective Device 1 1
Computer Operating System Problem 1 1
Charging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 24 24
No Known Impact Or Consequence To Patient 16 16
No Clinical Signs, Symptoms or Conditions 7 7
No Consequences Or Impact To Patient 4 4

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